Identity
- Trade Name
- Flash IP 3543 EUDAMED
- Device Name
- Flash IP 3543 EUDAMED
- Model / Reference
- Flash IP 3543 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809466040504 EUDAMED
- Basic UDI-DI
- 08809466040503W EUDAMED
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Flash IP 3543 by DIGIRAY Corp. — Class IIa — 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 | 08809466040503W | Class IIa | Active |
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Manufacturer
- Manufacturer
- DIGIRAY Corp.
- EUDAMED SRN
- KR-MF-000024601
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 1aea21d8-31ce-4c3c-be8e-4f2a0e9d531e 61 fields · synced Jun 14, 2026