Identity
- Trade Name
- Retina Lens EUDAMEDMediworks FDA UDI
- Generic Name
- Hand-held magnifier FDA UDI
- Device Name
- Retina Lens EUDAMED
- Model / Reference
- 20D EUDAMED78D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087512128 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875RetinaLensBH EUDAMED
- Direct Marketing DI
- 06945087512128 EUDAMED
- FDA Product Code
- HJL FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Hand-held magnifier FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1380 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
No
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
Retina Lens by Shanghai Mediworks Precision Instruments Co., Ltd. — Class I — 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 | 69450875RetinaLensBH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 8d2be464-d013-4e6a-bd7e-9b23c07e3270 61 fields · synced Jul 17, 2026
- FDA UDI 0863098b-d707-4bf2-aa8f-d45141dfecf1 32 fields · synced May 30, 2026