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PEDS 600 System
EUDAMEDClass IIb (EU MDR)
Ref 7095-9-8011_V005Ref 7095-9-8011_V066Ref 7095-9-8011_V080Ref 7095-9-8011_V013Ref 7095-9-8011_V017Ref 7095-9-8011_V029Ref 7095-9-8011_V052Ref 7095-9-8011_V009
Identity
- Trade Name
- PEDS 600 System EUDAMED
- Device Name
- PEDS 600 System EUDAMED
- Model / Reference
- 7095-9-8011_V005 EUDAMED7095-9-8011_V066 EUDAMED7095-9-8011_V080 EUDAMED7095-9-8011_V013 EUDAMED7095-9-8011_V017 EUDAMED7095-9-8011_V029 EUDAMED7095-9-8011_V052 EUDAMED7095-9-8011_V009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502642962 EUDAMED04260502645321 EUDAMED04260502645857 EUDAMED04260502642481 EUDAMED04260502643501 EUDAMED04260502644744 EUDAMED04260502645048 EUDAMED04260502643181 EUDAMED
- Basic UDI-DI
- 426050264X021ZH EUDAMED
- EMDN Code
- Z11039005 RADIOGENIC COMPLEXES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Stationary X-ray system for the creation of projection radiographs for medical diagnostics. Indicated for general-purpose examinations of patients in standing, sitting, or recumbent positions, particularly in space-restricted clinical environments. EUDAMEDThe 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 (9)
- EUDAMED b6a8315c-16d7-4090-94f1-f3ce2338a46b 61 fields · synced Aug 3, 2026
- EUDAMED 47cdad92-321d-4103-995a-d65ce6b710f2 61 fields · synced Jun 18, 2026
- EUDAMED 96224bdd-58e6-478c-af21-d26e53393eb4 61 fields · synced Jul 9, 2026
- EUDAMED fc02622b-be8d-43db-a50c-27f521c868e8 61 fields · synced Jul 10, 2026
- EUDAMED b8d4d452-56e2-4341-b1eb-af6cb45f3d6f 61 fields · synced Jul 14, 2026
- EUDAMED 20e30bb0-5d6b-44b7-a5f8-a29620cb7108 61 fields · synced Jul 22, 2026
- EUDAMED 6f639ccc-e8b0-4178-aa42-56f86fccc3a6 61 fields · synced Jul 22, 2026
- EUDAMED 0a75084d-9df6-4a54-81f2-cfdd5f70002f 61 fields · synced Aug 1, 2026
- EUDAMED 1ff47cdb-0066-4f6f-a53f-99490abf35e7 61 fields · synced Aug 3, 2026