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Operation Microscope
EUDAMEDClass I (EU MDR)
Ref OPT400EModel OPT-1000,OPT-2000,OPT-3000,OPT-4000, OPT-1000ent, OPT-1000,OPT-1200, OPT-1300E , OPT-1800E, OPT500E, OPT400E,JDY-I,JDY-II, JDY-Z,JDY-FHD, YDJ-FHD-1,DZY-16,DZY-16A,DZY-16B,JDY-12B, JDY-12BI, JDY-12B LED, JDY-12BI LED, JDY-12B II LED
Identity
- Trade Name
- Operation Microscope EUDAMED
- Device Name
- Operation Microscope EUDAMED
- Model / Reference
- OPT-1000,OPT-2000,OPT-3000,OPT-4000, OPT-1000ent, OPT-1000,OPT-1200, OPT-1300E , OPT-1800E, OPT500E, OPT400E,JDY-I,JDY-II, JDY-Z,JDY-FHD, YDJ-FHD-1,DZY-16,DZY-16A,DZY-16B,JDY-12B, JDY-12BI, JDY-12B LED, JDY-12BI LED, JDY-12B II LED EUDAMEDOPT400E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452347 EUDAMED
- Basic UDI-DI
- 697722645BTOM01QU 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
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
Operation Microscope by Nanjing Poweam Medical 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 | 697722645BTOM01QU | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6a7e984f-46aa-4a88-92a0-bb86ec706887 61 fields · synced Jun 19, 2026