Identity
- Trade Name
- PEDS 600 System EUDAMED
- Device Name
- PEDS 600 System EUDAMED
- Model / Reference
- 7095-9-8011_V055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502645123 EUDAMED
- Basic UDI-DI
- 426050264X021ZH EUDAMED
- EMDN Code
- Z11039005 RADIOGENIC COMPLEXES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The general-purpose diagnostic X-ray systems PEDS 600 are intended for various routine applications in planar X-ray imaging in human medicine. They are stationary systems that can be used both for analogue and digital imaging. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
PEDS 600 System by PROTEC X-ray Systems GmbH — Class IIb — 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 | 426050264X021ZH | Class IIb | Active |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-PR-000048508
Sources (1)
- EUDAMED d2042299-bc55-4915-9351-a63ed5cd4e9d 61 fields · synced Jun 18, 2026