Identity
- Trade Name
- OMS3500 Max EUDAMED
- Device Name
- Surgical Microscope EUDAMED
- Model / Reference
- 314V2840-L2-00 EUDAMED314V3750-R2-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095527299 EUDAMED06945095525462 EUDAMED
- Basic UDI-DI
- 69450955microscope7G EUDAMED
- Direct Marketing DI
- 06945095527299 EUDAMED06945095525462 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMEDZ12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
OMS3500 Max 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 (3)
- EUDAMED b91101fd-9b45-4e0e-b83a-4a8e44f0d2e1 61 fields · synced Oct 9, 2026
- EUDAMED 43d8629f-81b3-4893-9c5b-ced7bdf2acf3 61 fields · synced May 17, 2026
- EUDAMED 586d09be-2b3d-4f3b-8105-3339312955da 61 fields · synced Oct 9, 2026