Identity
- Trade Name
- OPTIMAX 2010 EUDAMED
- Device Name
- OPTIMAX 2010 EUDAMED
- Model / Reference
- 1160-2-8000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502640425 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 0a55184b-9292-43b0-8b83-508c18f5b6e9 61 fields · synced Jun 19, 2026