Euro
Custom EURO: Front/Back Protection One Piece- Velcro Closure w/ Elastic .25mm Regular Lead Size Female Three Extra Large, ULEURO-3XF
6manufacturers in China registered for this device type
390catalogue numbers in this listing
24recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | EAJ |
| Device type | Apron, Leaded |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLEURO6XLF | 6XL Female | In distribution |
| UBEURO8XLM | 8XL Male | In distribution |
| ULEUROXXLM | 2XL Male | In distribution |
| SCCEURO-6XM | In distribution | |
| RBEUROXXLF | 2XL Female | In distribution |
| UBEURO-LF | In distribution | |
| SLEURO-MM | In distribution | |
| UBEURO-SM | In distribution | |
| RLEURO5XLF | 5XL Female | In distribution |
| RLEURO*M | Tailored | In distribution |
| SBEUROC | Male large | In distribution |
| RBEUROXSM | XS Male | In distribution |
| STLEURO-XXM | In distribution | |
| STLEURO-PF | In distribution | |
| SCCEURO-8XM | In distribution | |
| UBEUROG | Female Large Plus | In distribution |
| SBEURO6XLM | 6XL Male | In distribution |
| RLEUROXSM | XS Male | In distribution |
| RTLEURO-7XM | In distribution | |
| RTLEURO-XSF | In distribution | |
| SLEUROG | Female Large Plus | In distribution |
| UBEURO5XLM | 5XL Male | In distribution |
| STLEURO-XSM | In distribution | |
| RTLEURO-5XM | In distribution | |
| SLEUROXLF | Female XL | In distribution |
| SBEUROXSF | XS Female | In distribution |
| SBEUROXXLM | 2XL Male | In distribution |
| RTLEURO-4XM | In distribution | |
| SBEURO-PLUS | In distribution | |
| RBEUROC | Male Large | In distribution |
| RTLEURO-XLM | In distribution | |
| RBEURO-2XM | XS Male | In distribution |
| UBEUROXSM | XS Male | In distribution |
| SLEURO5XLF | 5XL Female | In distribution |
| SBEURO3XLF | 3XL Female | In distribution |
| SBEUROXXLF | 2XL Female | In distribution |
| SBEURO-SF | In distribution | |
| RBEURO-3XF | XS Male | In distribution |
| RCCEURO-8XM | In distribution | |
| RLEURO-XLF | In distribution | |
| SLEUROXSF | XS Female | In distribution |
| SCCEURO-7XM | In distribution | |
| ECRBEUROD | Female Small | In distribution |
| UBEUROE | Female Medium | In distribution |
| SLEUROD | Female Small | In distribution |
| RTLEURO-3XM | In distribution | |
| SBEURO-SM | In distribution | |
| SCCEURO-XXF | In distribution | |
| ULEURO*F | Tailored | In distribution |
| RBEURO3XLM | 3XL Male | In distribution |
| RBEURO-2XF | XS Male | In distribution |
| ECSBEUROD | Female Small | In distribution |
| ULEUROB | Male Medium | In distribution |
| RTLEURO-3XF | In distribution | |
| RBEUROXLM | Male XL | In distribution |
| RLEUROXLF | Female XL | In distribution |
| ECSBEUROC | Male Large | In distribution |
| RCCEURO-5XM | In distribution | |
| SBEURO8XLM | 8XL Male | In distribution |
| SBEURO8XLF | 8XL Female | In distribution |
| ECSBEUROB | Male Medium | In distribution |
| UBEURO-LM | In distribution | |
| ULEURO7XLF | 7Xl Female | In distribution |
| RTLEURO-6XF | In distribution | |
| ECRBEUROB | Medium | In distribution |
| RLEURO7XLM | 7XL Male | In distribution |
| STLEURO-3XM | In distribution | |
| RBEUROD | Female Small | In distribution |
| ULEUROD | Female Small | In distribution |
| RLEURO-3XM | In distribution | |
| ECSLEUROE | Female Medium | In distribution |
| ULEURO-2XF | In distribution | |
| STLEURO-8XM | In distribution | |
| RLEURO-MM | In distribution | |
| ULEURO-SM | In distribution | |
| RLEURO7XLF | 7XL Female | In distribution |
| RBEURO5XLF | 5XL Female | In distribution |
| STLEURO-7XF | In distribution | |
| SLEURO4XLF | 4XL Female | In distribution |
| STLEURO-MM | In distribution | |
| RLEURO6XLM | 6XL Male | In distribution |
| SBEURO-LF | In distribution | |
| RBEUROXSM | XS Male | In distribution |
| ULEUROA | Male Small | In distribution |
| SCCEURO-MM | In distribution | |
| ULEURO6XLM | 6XL Male | In distribution |
| SLEURO-3XM | In distribution | |
| ULEURO-LM | In distribution | |
| RTLEURO-4XF | In distribution | |
| STLEURO-6XF | In distribution | |
| RLEURO-PLUS | In distribution | |
| RTLEURO-XXM | In distribution | |
| ECRLEUROA | Male Small | In distribution |
| SBEURO3XLM | 3XL Male | In distribution |
| ULEUROC | Male Large | In distribution |
| STLEURO-4XF | In distribution | |
| STLEURO-XXF | In distribution | |
| RCCEURO-XSM | In distribution | |
| SCCEURO-4XM | In distribution | |
| UBEUROXXLF | 2XL Female | In distribution |
| RBEUROXSMF | XS Female | In distribution |
| SBEUROB | Male Medium | In distribution |
| ULEUROXLM | Male XL | In distribution |
| REEURO3XLM | 3XL Male | In distribution |
| ECSBEUROXLF | XL Female | In distribution |
| RBEUROG | Female Large Plus | In distribution |
| RCCEURO-4XF | In distribution | |
| SBEURO*F | Tailored | In distribution |
| RCCEURO-7XM | In distribution | |
| RCCEURO-4XM | In distribution | |
| UBEURO6XLF | 6XL Female | In distribution |
| SBEUROF | Female Large | In distribution |
| UBEURO-MF | In distribution | |
| SLEUROF | Female Large | In distribution |
| RLEUROC | Male Large | In distribution |
| RLEURO-LM | In distribution | |
| ECSLEUROB | Male Medium | In distribution |
| UBEUROXSF | XS Female | In distribution |
| ULEUROG | Female Large Plus | In distribution |
| ECSBEUROE | Female Medium | In distribution |
| RLEURO-XLM | In distribution | |
| ECRLEUROXLM | Male Large | In distribution |
| RLEUROXSF | XS Female | In distribution |
| SLEURO-LM | In distribution | |
| RLEURO4XLM | 4XL Male | In distribution |
| RBEURO6XLF | 6XL Female | In distribution |
| ECRBEUROXLF | XL Female | In distribution |
| UBEURO*F | Tailored | In distribution |
| ECSLEUROXLM | Male Large | In distribution |
| SBEURO7XLM | 7XL Male | In distribution |
| RLEURO-SF | In distribution | |
| RTLEURO-LM | In distribution | |
| SBEURO5XLF | 5XL Female | In distribution |
| UBEUROXSM | XS Male | In distribution |
| RTLEURO-8XF | In distribution | |
| SBEUROXSF | XS Female | In distribution |
| SCCEURO-XLM | In distribution | |
| ECRLEUROC | Male Large | In distribution |
| SLEURO8XLM | 8XL Male | In distribution |
| RBEURO-LM | In distribution | |
| ULEURO-3XF | In distribution | |
| SLEUROXLM | Male Xl | In distribution |
| ULEURO5XLF | 5XL Female | In distribution |
| RLEUROXXLM | 2XL Male | In distribution |
| UBEURO5XLF | 5XL Female | In distribution |
| ULEUROXLF | Female XL | In distribution |
| SBEURO*M | Tailored | In distribution |
| UBEURO4XLM | 4XL Male | In distribution |
| UBEURO-PLUS | In distribution | |
| SCCEURO-MF | In distribution | |
| RCCEURO-XXM | In distribution | |
| UBEURO3XLM | 3XL Male | In distribution |
| UBEURO-SF | In distribution | |
| RCCEURO-SM | In distribution | |
| SBEUROXSM | XS Male | In distribution |
| UBEURO6XLM | 6Xl Male | In distribution |
| ECSLEUROXLF | Female Large | In distribution |
| SLEURO5XLM | 5XL Male | In distribution |
| RCCEURO-PF | In distribution | |
| SLEURO7XLM | 7XL Male | In distribution |
| STLEURO-XLF | In distribution | |
| RBEURO4XLF | 4XL Female | In distribution |
| RBEURO-SM | In distribution | |
| RTLEURO-SF | In distribution | |
| STLEURO-7XM | In distribution | |
| RLEUROB | Male Medium | In distribution |
| RLEURO-XXSF | In distribution | |
| SLEURO8XLF | 8XL Female | In distribution |
| RCCEURO-6XF | In distribution | |
| STLEURO-5XM | In distribution | |
| RBEURO*M | Tailored | In distribution |
| RLEUROXXLF | 2XL Female | In distribution |
| SBEURO-MM | In distribution | |
| RBEURO-LF | In distribution | |
| RCCEURO-6XM | In distribution | |
| RLEURO6XLF | 6XL Female | In distribution |
| RLEURO5XLM | 5XL Male | In distribution |
| ULEURO*M | Tailored | In distribution |
| SLEURO3XLF | 3XL Female | In distribution |
| UBEUROF | Female Large | In distribution |
| ECSBEUROF | Female Large | In distribution |
| ULEURO-SF | In distribution | |
| RLEUROG | Female Large Plus | In distribution |
| SCCEURO-5XF | In distribution | |
| SLEUROXSM | XS Male | In distribution |
| RLEUROF | Female Large | In distribution |
| RBEUROF | Female Large | In distribution |
| ULEUROE | Female Medium | In distribution |
| ULEUROXSF | XS Female | In distribution |
| SLEURO-XLF | In distribution | |
| ULEURO4XLF | 4XL Female | In distribution |
| SBEURO-LM | In distribution | |
| RCCEURO-XLF | In distribution | |
| UBEURO7XLF | 7XL Female | In distribution |
| RBEUROXLF | Female XL | In distribution |
| ULEURO5XLM | 5XL Male | In distribution |
| SLEURO-SM | In distribution | |
| RLEURO3XLM | 3XL Male | In distribution |
| SLEUROB | Male Medium | In distribution |
| RBEUROE | Female Medium | In distribution |
| SLEURO-XXSF | In distribution | |
| SCCEURO-3XM | In distribution | |
| RTLEURO-7XF | In distribution | |
| UBEURO-3XF | XS Male | In distribution |
| RTLEURO-XXF | In distribution | |
| RBEURO7XLF | 7XL Female | In distribution |
| SBEURO-2XM | XS Male | In distribution |
| STLEURO-MF | In distribution | |
| RTLEURO-MF | In distribution | |
| SLEURO-PLUS | In distribution | |
| RBEURO-SF | In distribution | |
| SCCEURO-XLF | In distribution | |
| ECSBEUROA | Male Small | In distribution |
| RBEURO5XLM | 5XL Male | In distribution |
| SLEURO-2XF | In distribution | |
| RLEURO-XSM | In distribution | |
| UBEURO-2XM | XS Male | In distribution |
| ULEURO-2XM | In distribution | |
| UBEUROC | Male Large | In distribution |
| SLEUROXSF | XS Female | In distribution |
| RCCEURO-XSF | In distribution | |
| ULEURO3XLF | 3XL Female | In distribution |
| ECRBEUROXLM | XL Male | In distribution |
| SLEURO3XLM | 3XL Male | In distribution |
| SBEURO-MF | In distribution | |
| SCCEURO-6XF | In distribution | |
| UBEUROXXLM | 2Xl Male | In distribution |
| SLEUROE | Female Medium | In distribution |
| RLEUROA | Male Small | In distribution |
| ULEURO-PLUS | In distribution | |
| RTLEURO-PF | In distribution | |
| UBEUROXSF | XS Female | In distribution |
| ULEURO-XLF | In distribution | |
| RBEURO4XLM | 4XL Male | In distribution |
| ECSLEUROA | Male Small | In distribution |
| UBEURO7XLM | 7XL Male | In distribution |
| ECRBEUROC | Male Large | In distribution |
| RBEURO8XLF | 8XL Female | In distribution |
| ECSLEUROC | Male Large | In distribution |
| RLEURO4XLF | 4XL Female | In distribution |
| SLEURO-XSM | In distribution | |
| ULEUROXSM | XS Male | In distribution |
| ULEURO8XLM | 8XL Male | In distribution |
| STLEURO-8XF | In distribution | |
| RTLEURO-MM | In distribution | |
| UBEURO-2XF | XS Male | In distribution |
| SBEURO4XLM | 4XL Male | In distribution |
| SCCEURO-XSF | In distribution | |
| ECSLEUROD | Female Small | In distribution |
| RCCEURO-LF | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
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|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,161 |
| Wolf X-Ray | Flow X-Ray Corp. | 909 |
| ComfortLite | Aadco Medical, Inc. | 538 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 402 |
| Rayshield | Aadco Medical, Inc. | 380 |
| 601 | Burlington Medical, LLC | 352 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
| F112 | Burlington Medical, LLC | 283 |
Showing 12 of 118. All products under Apron, Leaded
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 129 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 210 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 332 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 22 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 37 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 49 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 48 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 1 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2190 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 6 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 51 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 807 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 3 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 310 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 104 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 39 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.