Identity
- Trade Name
- Mediworks FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- Corneal Tomographer EUDAMEDCorneal topography system FDA UDI
- Model / Reference
- DEA520 EUDAMEDFDA UDI
- Description
- Corneal topography system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087500002 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875DEA520HC EUDAMED
- Direct Marketing DI
- 06945087500002 EUDAMED
- FDA Product Code
- MMQ FDA UDI
- EMDN Code
- Z12120107 PHOTOCHERATOSCOPES EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1350 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
Corneal Tomographer by Shanghai Mediworks Precision Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69450875DEA520HC | 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 529d0bdf-fc05-4c98-a28c-3cdc267eafb5 61 fields · synced Jun 19, 2026
- FDA UDI 93e2394c-b657-4e4f-bf62-3e0e9ba2be61 33 fields · synced May 30, 2026