Identity
- Trade Name
- Mediworks FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- Ophthalmic Surgical Microscope EUDAMEDSurgical Microscope FDA UDI
- Model / Reference
- SM621 EUDAMEDFDA UDI
- Description
- Surgical Microscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087500026 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875SurgicalMicro3C EUDAMED
- Direct Marketing DI
- 06945087500026 EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Ophthalmic surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 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
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
Ophthalmic Surgical Microscope by Shanghai Mediworks Precision Instruments Co., Ltd. — Class I — 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 | 69450875SurgicalMicro3C | 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 af4deedc-d77e-4f5a-b99a-b17edf2bd211 61 fields · synced Jun 19, 2026
- FDA UDI 878ee85d-c81d-4160-9f31-302c9ee5c432 33 fields · synced May 30, 2026