Identity
- Trade Name
- Surgical Microscopes EUDAMED
- Device Name
- Surgical Microscopes EUDAMED
- Model / Reference
- SM610 EUDAMEDSM628S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945087500309 EUDAMED
- Basic UDI-DI
- 69450875SurgicalMicrosFH EUDAMED
- Direct Marketing DI
- 06945087500309 EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Surgical Microscopes by Shanghai Mediworks Precision Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450875SurgicalMicrosFH | Class I | Active |
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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 (1)
- EUDAMED dce0c01f-5f29-400c-ac48-8313cf6408d0 61 fields · synced Jun 20, 2026