← Back to catalogue
Operating Microscope
EUDAMEDClass I (EU MDR)
Ref 561CP0002Model OPM500/OPM500C/OPM500D
Identity
- Device Name
- Operating Microscope EUDAMED
- Model / Reference
- OPM500/OPM500C/OPM500D EUDAMED561CP0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972039970293 EUDAMED
- Basic UDI-DI
- 697203997YKAERY EUDAMED
- Direct Marketing DI
- 06972039970293 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Operating Microscope by Shenzhen Certainn Technology 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 | 697203997YKAERY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen CERTAINN Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016915
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 67db7c9e-f9ce-43ed-b691-d4c6d680469b 61 fields · synced Jul 14, 2026