Welch Allyn, Inc.
Welch Allyn 3.5 V Halogen HPX Ophthalmic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter on Corneal Viewing Lens (#11820), Prestige Coaxial-Plus Ophthalmoscope (#11735),…
Welch Allyn 3.5 V Halogen HPX Ophthalmic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter on Corneal Viewing Lens (#11820), Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 120-Minute Power Handle(s), Universal Desk Charger, Hard Storage Case, Training Fundus Eyebox (#SM2383), Fixation Cards, Charging Well Adapter; 2 Lithium-Ion (#71960) Batteries; IEC Plug Type-A
43manufacturers in China registered for this device type
247catalogue numbers in this listing
9510(k) clearances naming this product code
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 | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | ERA |
| Device type | Otoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4770 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-08 |
| Record revised | 2025-03-26 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 20, pack of 16, pack of 25, pack of 4, pack of 6 |
| Distribution end date | 2025-04-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901080 | In distribution | ||
| 901001 | In distribution | ||
| 901081 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901020 | In distribution | ||
| 901026 | In distribution | ||
| 901027 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 25 | In distribution | |
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901079 | In distribution | ||
| 901090 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901081 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | 48 | In distribution | |
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901080 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901001 | In distribution | ||
| 901021 | In distribution | ||
| 901027 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901082 | In distribution | ||
| 901080 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 34 | In distribution | |
| 901080 | In distribution | ||
| 901080 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901081 | In distribution | ||
| 901021 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901081 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901082 | In distribution | ||
| 901079 | In distribution | ||
| 901079 | In distribution | ||
| 901082 | In distribution | ||
| 901079 | In distribution | ||
| 901080 | In distribution | ||
| 901079 | In distribution | ||
| 901082 | In distribution | ||
| 901080 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901080 | In distribution | ||
| 901021 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901080 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901080 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901080 | In distribution | ||
| 901079 | In distribution | ||
| 901021 | In distribution | ||
| 901026 | In distribution | ||
| 901081 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 80 | In distribution | |
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 25 | In distribution | |
| 901087 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 34 | In distribution | |
| 901001 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901087 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901021 | In distribution | ||
| 901021 | In distribution | ||
| 901081 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901080 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901001 | 34 | In distribution | |
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 25 | In distribution | |
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901079 | In distribution | ||
| 901001 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901027 | In distribution | ||
| 901026 | In distribution | ||
| 901001 | 34 | In distribution | |
| 901026 | In distribution | ||
| 901079 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901026 | In distribution | ||
| 901082 | In distribution | ||
| 901026 | In distribution | ||
| 901021 | In distribution | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901082 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901089 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901081 | Withdrawn | ||
| 901089 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901089 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901079 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901026 | Withdrawn | ||
| 901081 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostix™ | American Diagnostic Corp. | 366 |
| 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 |
| Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 8 |
Showing 12 of 247. All products under Otoscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K955043 | 1995-11-14 |
| K952578 | 1995-07-10 |
| K950787 | 1995-04-06 |
| K943916 | 1994-08-25 |
| K831709 | 1983-06-30 |
| K782142 | 1979-01-26 |
| K781029 | 1978-06-28 |
| K770770 | 1977-04-29 |
| K770769 | 1977-04-29 |
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.