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Operating Microscope
EUDAMEDClass I (EU MDR)
Ref 560CP0003Model OPM500/OPM500C/OPM500D
Identity
- Device Name
- Operating Microscope EUDAMED
- Model / Reference
- OPM500/OPM500C/OPM500D EUDAMED560CP0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972039970286 EUDAMED
- Basic UDI-DI
- 697203997YKAERY EUDAMED
- Direct Marketing DI
- 06972039970286 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 |
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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 6994df6f-d818-4419-8cff-32e07782401a 61 fields · synced Jun 18, 2026