Identity
- Trade Name
- DR 600 FLFS Horizontal Overlay EUDAMED
- Device Name
- DR Overlay EUDAMED
- Model / Reference
- 53B1J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904187463 EUDAMED
- Basic UDI-DI
- 5414904272664YM EUDAMED
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
DR 600 FLFS Horizontal Overlay by Agfa NV — 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 | 5414904272664YM | Class I | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (1)
- EUDAMED 2e451404-489c-40fe-be4a-74427d7dbdce 61 fields · synced Jul 16, 2026