N.100 Speculum 4.3MM
Catalogue number BTS-322, listed by Bellegrove Medical Supply, Inc., United States, under Otoscope. 43 manufacturers in China are registered for this product code.
43manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (15), Guangdong (15), Jiangsu (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Showing 12 of 43. All 43 manufacturers in China registered for Otoscope
Record
| Listed by | Bellegrove Medical Supply, Inc., United States |
|---|---|
| FDA product code | ERA |
| Device type | Otoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4770 |
| Premarket notification | Exempt |
| Record published | 2021-10-11 |
| Record revised | 2022-09-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Distribution end date | 2022-09-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BTS-322 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostix™ | American Diagnostic Corp. | 366 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 247 |
| Prosidio | Prosidio LLC | 38 |
| mytaMed | Mytamed, Inc. | 33 |
| Adstation™ | American Diagnostic Corp. | 33 |
| Jedmed | Jedmed Instrument Company | 32 |
| zumax | Zumax Medical Co., Ltd. | 21 |
| Otoscope | Karl Storz GmbH & Co. KG | 17 |
| Firefly | Firefly Global | 12 |
| Otopront | Happersberger Otopront Gmbh | 11 |
| Bear | Mytamed, Inc. | 10 |
| Otoscope | Ecleris SRL | 9 |
Showing 12 of 247. All products under Otoscope
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.