Identity
- Trade Name
- OMS2000 EUDAMED
- Device Name
- Surgical Microscope EUDAMED
- Model / Reference
- 250V0040-29 EUDAMED250V4740-28L1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095526421 EUDAMED06945095527008 EUDAMED
- Basic UDI-DI
- 69450955microscope7G EUDAMED
- Direct Marketing DI
- 06945095526421 EUDAMED06945095527008 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Oms2000 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 (2)
- EUDAMED d10330c6-fc89-4f8a-8ad2-354af87984cc 61 fields · synced Oct 6, 2026
- EUDAMED faaea28a-66ba-4a44-af96-1321d35b53cf 61 fields · synced May 17, 2026