Speculum
EAR, Zoellner, NO. 5, Oval, Black, 9.5 X 10.5 MM
9manufacturers in China registered for this device type
59catalogue 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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-08 |
| Record revised | 2024-08-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36-134-02-14 | 4.5 CM | In distribution |
| 36-859-90-07 | 14.5 CM | In distribution |
| 36-112-11-01 | 4 CM | In distribution |
| 36-134-07-07 | 4.5 CM | In distribution |
| 36-845-03-07 | 16 CM | In distribution |
| 36-845-02-07 | 16 CM | In distribution |
| 24-999-09-07 | In distribution | |
| 36-134-03-14 | 4.5 CM | In distribution |
| 36-856-03-07 | 14.5 CM | In distribution |
| 24-999-11-07 | In distribution | |
| 36-112-13-01 | 4 CM | In distribution |
| 48-261-45-07 | 14 CM | In distribution |
| 36-858-14-07 | 14.5 CM | In distribution |
| 36-134-03-07 | 4.5 CM | In distribution |
| 36-843-02-07 | 14 CM | In distribution |
| 36-134-05-14 | 4.5 CM | In distribution |
| 36-112-12-01 | 4 CM | In distribution |
| 36-132-05-14 | 4 CM | In distribution |
| 48-261-70-14 | 14 CM | In distribution |
| 36-132-02-14 | 4 CM | In distribution |
| 36-843-01-07 | 14 CM | In distribution |
| 36-861-75-07 | 14 CM | In distribution |
| 36-112-10-01 | 4 CM | In distribution |
| 36-843-03-07 | 14 CM | In distribution |
| 36-134-01-14 | 4.5 CM | In distribution |
| 36-134-06-07 | 4.5 CM | In distribution |
| 36-132-02-04 | 4 CM | In distribution |
| 36-134-07-14 | 4.5 CM | In distribution |
| 36-132-03-14 | 4 CM | In distribution |
| 36-856-02-07 | 14 CM | In distribution |
| 36-112-14-01 | 4 CM | In distribution |
| 48-261-30-14 | 14 CM | In distribution |
| 36-849-13-07 | 12.5 CM | In distribution |
| 36-859-75-07 | 14 CM | In distribution |
| 36-132-05-04 | 4 CM | In distribution |
| 36-134-06-14 | 4.5 CM | In distribution |
| 36-856-01-07 | 13 CM | In distribution |
| 36-852-13-07 | 13 CM | In distribution |
| 24-999-07-07 | In distribution | |
| 36-859-35-07 | 13 CM | In distribution |
| 36-845-01-07 | 15.5 CM | In distribution |
| 36-134-04-14 | 4.5 CM | In distribution |
| 36-132-01-14 | 4 CM | In distribution |
| 36-856-04-07 | 15 CM | In distribution |
| 36-134-05-07 | 4.5 CM | In distribution |
| 48-261-45-14 | 14 CM | In distribution |
| 36-859-50-07 | 14 CM | In distribution |
| 36-118-12-01 | 4 CM | In distribution |
| 36-848-13-07 | 13 CM | In distribution |
| 36-134-02-07 | 4.5 CM | In distribution |
| 48-261-30-07 | Withdrawn | |
| 36-134-01-07 | Withdrawn | |
| 36-132-03-04 | Withdrawn | |
| 36-861-75-14 | 14 CM | Withdrawn |
| 48-261-70-07 | Withdrawn | |
| 36-861-45-07 | Withdrawn | |
| 36-132-01-04 | Withdrawn | |
| 36-134-04-07 | Withdrawn | |
| 36-861-45-14 | 13.5 CM | Withdrawn |
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 |
| Jedmed | Jedmed Instrument Company | 106 |
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.