Identity
- Trade Name
- MediWorks FDA UDI
- Generic Name
- Vision/eye movement analysis system FDA UDI
- Device Name
- Vision Screeners EUDAMEDThe vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases. FDA UDI
- Model / Reference
- V100 EUDAMEDFDA UDI
- Description
- The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087510018 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875VisionScreenerLW EUDAMED
- Direct Marketing DI
- 06945087510018 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Vision/eye movement analysis system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vision Screeners by Shanghai Mediworks Precision Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450875VisionScreenerLW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Mediworks Precision Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000004251
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 4878ce24-5bb8-4e33-841c-85795756a4e5 61 fields · synced Jun 19, 2026
- FDA UDI 9b61b1b6-3c05-4633-905d-0724ce9a5f1b 33 fields · synced May 30, 2026