Identity
- Trade Name
- OPTIMAX 2010 EUDAMED
- Device Name
- OPTIMAX 2010 EUDAMED
- Model / Reference
- 1160-9-2800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502640456 EUDAMED
- Basic UDI-DI
- 426050264A002UC EUDAMED
- EMDN Code
- Z11070701 TRADITIONAL PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Optimax 2010 by PROTEC X-ray Systems GmbH — 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 | 426050264A002UC | Class I | Active |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-MF-000048351
Sources (1)
- EUDAMED d8a9a7bc-e485-4db9-bff2-078e1c027aa4 61 fields · synced Jul 9, 2026