Identity
- Trade Name
- OPTIMAX Mammo EUDAMED
- Device Name
- OPTIMAX EUDAMED
- Model / Reference
- 1171-9-8000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502640401 EUDAMED
- Basic UDI-DI
- 426050264A001UA 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 Mammo 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 | 426050264A001UA | Class I | Active |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-MF-000048351
Sources (1)
- EUDAMED e21041f4-5394-4981-8cc4-cfdec77cdb07 61 fields · synced Jul 24, 2026