EOS
EosSpec II-EOS DISPOSABLE VAGINAL SPECULUM,TWIST LOCK, MEDIUM SIZE
40manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Zhejiang (15), Shanghai (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
Showing 12 of 40. All 40 manufacturers in China registered for Speculum, Vaginal, Nonmetal
Record
| Listed by | North EOS Industries, Inc., Taiwan |
|---|---|
| FDA product code | HIB |
| Device type | Speculum, Vaginal, Nonmetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Manufacturer |
| 510(k) | K963377 |
| Record published | 2018-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EosSpec III-RATCHET LARGE | In distribution | |
| EosSpec I -MEDIUM | In distribution | |
| EosSpec I -XM(SMOKE TUBE) | In distribution | |
| EosSpec I -LARGE | In distribution | |
| EosSpec I -XL | In distribution | |
| EosSpec V -SIMS SMALL | In distribution | |
| EosSpec I -SLIM/L | In distribution | |
| EosSpec II -TWIST LOCK LARGE | In distribution | |
| EosSpec I -XM | In distribution | |
| EosSpec III -RATCHET MEDIUM | In distribution | |
| EosSpec III -RATCHET SMALL | In distribution | |
| EosSpec V- -SIMS MEDIUM | In distribution | |
| EosSpec II -TWIST LOCK MEDIUM | In distribution | |
| EosSpec I -S/M | In distribution | |
| EosSpec I -SLIM/M | In distribution | |
| EosSpec V – SIMS LARGE | In distribution | |
| EosSpec II -TWIST LOCK SMALL | In distribution | |
| EosSpec I -mini | In distribution | |
| EosSpec I -SMALL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 30 |
| Vagispec Kolplast | Kolplast C I | 19 |
| Shengbo | Yuhuan City Shengbo Mould Manufacturing Co., Ltd. | 18 |
| Centurion | Centurion Medical Products Corporation | 13 |
| ClearSpec | Clearspec, LLC | 12 |
| Speculux | Evexar Medical Limited | 12 |
| McKesson. | Mckesson Medical-Surgical Inc. | 11 |
| Instraspec | Robinson Healthcare Limited | 10 |
| PremierPro | Prestige Ameritech | 9 |
| Bioseal Inc. | Bioseal | 9 |
| ER-Spec/Office-Spec | OBP Medical Corporation | 6 |
| Medline | Medline Industries, Inc. | 6 |
Showing 12 of 75. All products under Speculum, Vaginal, Nonmetal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963377 | 1996-10-04 |
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.