Identity
- Trade Name
- DR 100e EUDAMED
- Device Name
- DR 100e 6012 EUDAMED
- Model / Reference
- XBVBO EUDAMEDXBVCQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904231975 EUDAMED05414904231968 EUDAMED
- Basic UDI-DI
- 5414904272855YW EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb 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
Category: Stationary basic diagnostic x-ray system, digital
DR 100e by Agfa NV — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: en-in
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 | 5414904272855YW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED a9045448-f0c8-4b3f-bbc5-ca0cea3e2d64 61 fields · synced Jul 11, 2026
- EUDAMED ad89f474-4d08-44f9-ba5b-2a3d3b945e2d 61 fields · synced May 19, 2026