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Operation Microscope
EUDAMEDClass I (EU MDR)
Ref JDY-IIModel 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 LEDRef JDY-IRef YDJ-FHD-1Ref OPT500ERef JDY-12BRef OPT-1000entRef JDY-12B II LEDRef DZY-16Ref JDY-FHDRef JDY-Z
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 EUDAMEDJDY-II EUDAMEDJDY-I EUDAMEDYDJ-FHD-1 EUDAMEDOPT500E EUDAMEDJDY-12B EUDAMEDOPT-1000ent EUDAMEDJDY-12B II LED EUDAMEDDZY-16 EUDAMEDJDY-FHD EUDAMEDJDY-Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452361 EUDAMED06977226452354 EUDAMED06977226452392 EUDAMED06977226452330 EUDAMED06977226452439 EUDAMED06977226452293 EUDAMED06977226452477 EUDAMED06977226452408 EUDAMED06977226452385 EUDAMED06977226452378 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 (10)
- EUDAMED 09ba7ce8-9631-4ad0-a150-baf5baad5994 61 fields · synced Oct 6, 2026
- EUDAMED 25e7aaf3-519f-40e4-a03c-999b0dddde7f 61 fields · synced May 16, 2026
- EUDAMED 41a78d2f-3b54-446d-bd8b-ab28b278d27a 61 fields · synced May 16, 2026
- EUDAMED 5f8bb13b-8532-46a3-866b-a5ac1d8cef89 61 fields · synced May 17, 2026
- EUDAMED dccde2ac-9407-4e9c-b7f1-5e0eea1f5cc1 61 fields · synced May 17, 2026
- EUDAMED 33db3092-ad59-454d-a26f-a054e7600512 61 fields · synced May 18, 2026
- EUDAMED 195fe183-d74a-44e0-bc34-7379ef91ca2e 61 fields · synced May 18, 2026
- EUDAMED 3abd1f84-73ca-47de-944d-4b3745330255 61 fields · synced May 18, 2026
- EUDAMED beae7dcd-2d3b-4b80-9b7d-3becf1af9ae3 61 fields · synced May 18, 2026
- EUDAMED 27902feb-a7c9-4364-8018-4dfe4eb44e72 61 fields · synced May 18, 2026