Bear
Gruber Ear Specula, XL, Oval, 42mm, 7.0 x 8.2mm
9manufacturers in China registered for this device type
60catalogue 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 | Mytamed, Inc. |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2025-06-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.05.23 | Withdrawn | |
| 6.07.000 | Withdrawn | |
| 6.02.19 | Withdrawn | |
| 6.05.16 | Withdrawn | |
| 6.06.75 | Withdrawn | |
| 6.05.14 | Withdrawn | |
| 6.06.40 | Withdrawn | |
| 6.07.02 | Withdrawn | |
| 6.07.05 | Withdrawn | |
| 6.06.45 | Withdrawn | |
| 6.05.13 | Withdrawn | |
| 6.05.17 | Withdrawn | |
| 6.05.22 | Withdrawn | |
| 6.07.01 | Withdrawn | |
| 6.05.27 | Withdrawn | |
| 6.05.02 | Withdrawn | |
| 6.05.20 | Withdrawn | |
| 6.05.07 | Withdrawn | |
| 6.02.15 | Withdrawn | |
| 6.05.05 | Withdrawn | |
| 6.02.16 | Withdrawn | |
| 7.15.50 | Withdrawn | |
| 6.05.26 | Withdrawn | |
| 6.05.25 | Withdrawn | |
| 6.05.09 | Withdrawn | |
| 6.06.70 | Withdrawn | |
| 6.02.12 | Withdrawn | |
| 6.05.00 | Withdrawn | |
| 6.05.21 | Withdrawn | |
| 6.05.24 | Withdrawn | |
| 6.05.10 | Withdrawn | |
| 6.07.00 | Withdrawn | |
| 6.02.17 | Withdrawn | |
| 6.06.65 | Withdrawn | |
| 6.06.30 | Withdrawn | |
| 6.05.08 | Withdrawn | |
| 7.14.01 | Withdrawn | |
| 6.05.06 | Withdrawn | |
| 6.02.18 | Withdrawn | |
| 6.05.01 | Withdrawn | |
| 7.14.02 | Withdrawn | |
| 7.15.90 | Withdrawn | |
| 6.05.03 | Withdrawn | |
| 6.05.11 | Withdrawn | |
| 6.02.13 | Withdrawn | |
| 7.14.03 | Withdrawn | |
| 6.06.60 | Withdrawn | |
| 7.15.75 | Withdrawn | |
| 6.06.50 | Withdrawn | |
| 6.06.55 | Withdrawn | |
| 6.05.12 | Withdrawn | |
| 6.05.19 | Withdrawn | |
| 6.05.15 | Withdrawn | |
| 6.06.80 | Withdrawn | |
| 7.15.35 | Withdrawn | |
| 6.05.18 | Withdrawn | |
| 6.06.35 | Withdrawn | |
| 6.02.14 | Withdrawn | |
| 6.05.04 | Withdrawn | |
| 6.07.03 | 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.