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OMS3000 Pro
EUDAMEDClass I (EU MDR)
Ref 227V3842-00Ref 227V3742-00Ref 228V3750-00Ref 228V3740-00Ref 820110-10152-000
Identity
- Trade Name
- OMS3000 Pro EUDAMEDOMS3000 EUDAMED
- Device Name
- Surgical Microscope EUDAMED
- Model / Reference
- 227V3842-00 EUDAMED227V3742-00 EUDAMED228V3750-00 EUDAMED228V3740-00 EUDAMED820110-10152-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095525530 EUDAMED06945095525523 EUDAMED06945095526773 EUDAMED06945095525561 EUDAMED06945095527763 EUDAMED
- Basic UDI-DI
- 69450955microscope7G EUDAMED
- Direct Marketing DI
- 06945095525530 EUDAMED06945095525523 EUDAMED06945095526773 EUDAMED06945095525561 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMEDZ12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMEDGermany 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
OMS3000 Pro by Zumax 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 | 69450955microscope7G | Class I | Active |
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Manufacturer
- Manufacturer
- Zumax Medical CO., LTD.
- EUDAMED SRN
- CN-MF-000011126
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (5)
- EUDAMED 14f3b2db-6b32-4062-b398-e25c4a1fdcc1 61 fields · synced Oct 7, 2026
- EUDAMED df0ddf4d-980e-491d-a214-ed87685cb4ef 61 fields · synced May 16, 2026
- EUDAMED cff0102f-a11a-4f5d-a1b9-f9777516bf3d 61 fields · synced May 16, 2026
- EUDAMED 0d328501-0812-449f-8fcc-570a242df21d 61 fields · synced May 18, 2026
- EUDAMED 6ac39059-f857-4fea-b3f3-139a6adf4bc7 61 fields · synced Jul 8, 2026