Welch Allyn, Inc.
Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic…
Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
Who Else Makes It
Concentrated in Chongqing (5), Jiangsu (3), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Showing 12 of 14. All 14 manufacturers in China registered for Camera, Ophthalmic, General-Use
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | PJZ |
| Device type | Camera, Ophthalmic, General-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-30 |
| Record revised | 2022-06-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2024-02-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901103 | In distribution | |
| 901101 | In distribution | |
| 901124 | In distribution | |
| 901102 | In distribution | |
| 901103 | In distribution | |
| 901122 | In distribution | |
| 901122 | In distribution | |
| 901122 | In distribution | |
| 901124 | Withdrawn | |
| 901103 | Withdrawn | |
| 901124 | Withdrawn | |
| 901124 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3nethra | Forus Health Pvt.ltd., | 12 |
| Welch Allyn | Medimaging Integrated Solution Inc. | 6 |
| Fundus Camera | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 6 |
| D-EYE | D-EYE SRL | 4 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| EyeCaster | Innovations Lightx Inc | 3 |
| Paxos Scope | Digisight Technologies, Inc. | 3 |
| Remidio | Remidio Innovative Solutions Inc | 3 |
| Volk Viva | Volk Optical Inc. | 2 |
| Volk VistaView | Volk Optical Inc. | 2 |
| PanoCam™ PRO | Visunex Medical Systems Inc. | 2 |
Showing 12 of 48. All products under Camera, Ophthalmic, General-Use
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.