Identity
- Trade Name
- INTERFACE BOX EUDAMED
- Device Name
- INTERFACE BOX EUDAMED
- Model / Reference
- 4499-9-8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502642467 EUDAMED
- Basic UDI-DI
- 426050264D004V5 EUDAMED
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES 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
Interface Box 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 | 426050264D004V5 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-MF-000048351
Sources (1)
- EUDAMED f967847a-df15-47c8-b781-92f2b853a0bf 61 fields · synced Jun 20, 2026