Otoscope
Ear Speculum for 121200 and 121210, 4 mm
43manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | ERA |
| Device type | Otoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4770 |
| Premarket notification | Exempt |
| Record published | 2019-02-23 |
| Record revised | 2024-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 121204S | 100 | In distribution | |
| 119800 | In distribution | ||
| 495EW | In distribution | ||
| 119515 | In distribution | ||
| 119500 | In distribution | ||
| 119700 | In distribution | ||
| 1218AL | In distribution | ||
| 1215AT | In distribution | ||
| 119650 | In distribution | ||
| 121210 | In distribution | ||
| 119900 | In distribution | ||
| 1218AT | In distribution | ||
| 121204 | 1,000 | In distribution | |
| 1228D | In distribution | ||
| 1218BL | In distribution | ||
| 1228C | In distribution | ||
| 121200 | In distribution |
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 |
| Firefly | Firefly Global | 12 |
| Otopront | Happersberger Otopront Gmbh | 11 |
| Bear | Mytamed, Inc. | 10 |
| Otoscope | Ecleris SRL | 9 |
| Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 8 |
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.