Penguin ENT Scope Model
Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique…
Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.
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 | Opcom Inc., Taiwan |
|---|---|
| FDA product code | ERA |
| Device type | Otoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4770 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP1313F6 | In distribution | |
| CP1310F6 | 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 |
| 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.