Jedmed
Speculum EAR Hartmann Oval Ebony Size 1
9manufacturers in China registered for this device type
106catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-0228 3 | In distribution | |
| 52-1020 | In distribution | |
| 32-0237 2 | In distribution | |
| 32-0144 | In distribution | |
| 32-0238 5 | In distribution | |
| 52-2182 | In distribution | |
| 32-0236 1 | In distribution | |
| 32-0236 6 | In distribution | |
| 32-0154 | In distribution | |
| 32-0236 2 | In distribution | |
| 32-0227 3 | In distribution | |
| 32-0246 1 | In distribution | |
| 32-0141 | In distribution | |
| 32-0266 1 | In distribution | |
| 32-0227 1 | In distribution | |
| 32-0248 1 | In distribution | |
| 32-0228 7 | In distribution | |
| 52-1032 | In distribution | |
| 32-0364 | In distribution | |
| 32-0238 2 | In distribution | |
| 32-0226 7 | In distribution | |
| 32-0226 4 | In distribution | |
| 32-0229 3 | In distribution | |
| 32-0239 6 | In distribution | |
| 32-0248 4 | In distribution | |
| 52-2117 | In distribution | |
| 52-1050 | In distribution | |
| 32-0226 6 | In distribution | |
| 32-0266 3 | In distribution | |
| 32-0229 4 | In distribution | |
| 32-0256 1 | In distribution | |
| 52-2121 | In distribution | |
| 32-0365 | In distribution | |
| 32-0246 3 | In distribution | |
| 32-0238 6 | In distribution | |
| S381458 | In distribution | |
| 32-0236 4 | In distribution | |
| 32-0227 7 | In distribution | |
| 32-0151 | In distribution | |
| 32-0256 3 | In distribution | |
| 32-1280 | In distribution | |
| 39-8414 | In distribution | |
| 52-1031 | In distribution | |
| 32-0237 3 | In distribution | |
| 32-0228 1 | In distribution | |
| 32-0236 5 | In distribution | |
| 32-0236 3 | In distribution | |
| 32-0248 3 | In distribution | |
| 32-0229 5 | In distribution | |
| 32-0363 | In distribution | |
| 32-0239 5 | In distribution | |
| 32-0248 2 | In distribution | |
| 32-0229 1 | In distribution | |
| 32-0227 6 | In distribution | |
| 52-2200 | In distribution | |
| S381460 | In distribution | |
| 32-0239 7 | In distribution | |
| 32-0143 | In distribution | |
| 32-0239 2 | In distribution | |
| 32-0226 3 | In distribution | |
| 32-0238 7 | In distribution | |
| 52-2183 | In distribution | |
| 32-0246 2 | In distribution | |
| 52-2123 | In distribution | |
| 32-0256 2 | In distribution | |
| 32-0239 4 | In distribution | |
| S381462 | In distribution | |
| 32-0238 1 | In distribution | |
| 52-2115 | In distribution | |
| 32-0236 7 | In distribution | |
| 32-0142 | In distribution | |
| 52-2181 | In distribution | |
| 32-0362 | In distribution | |
| 32-0152 | In distribution | |
| 32-0227 2 | In distribution | |
| 32-0153 | In distribution | |
| 32-0237 7 | In distribution | |
| 32-0226 5 | In distribution | |
| 32-0237 5 | In distribution | |
| 32-0237 4 | In distribution | |
| 32-0228 5 | In distribution | |
| 52-2122 | In distribution | |
| 32-0237 1 | In distribution | |
| 32-0238 4 | In distribution | |
| 32-0226 2 | In distribution | |
| 32-0237 6 | In distribution | |
| 32-0229 6 | In distribution | |
| 32-0360 | In distribution | |
| 32-0266 2 | In distribution | |
| 32-0228 6 | In distribution | |
| 32-0226 1 | In distribution | |
| 32-0239 1 | In distribution | |
| 32-0238 3 | In distribution | |
| 32-0229 2 | In distribution | |
| 52-1033 | In distribution | |
| 32-0361 | In distribution | |
| 52-2116 | In distribution | |
| 32-0227 4 | In distribution | |
| 32-0227 5 | In distribution | |
| 52-2050 | In distribution | |
| 32-0246 4 | In distribution | |
| 32-0239 3 | In distribution | |
| 32-0229 7 | In distribution | |
| 32-0228 4 | In distribution | |
| 32-0228 2 | In distribution | |
| S381464 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Sklar® | Sklar Corporation | 180 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 104 |
Showing 12 of 260. All products under Speculum, Ent
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.