Identity
- Trade Name
- DRYSTAR DT 2 B EUDAMED
- Device Name
- Hard Copy Film EUDAMED
- Model / Reference
- EKL38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904025574 EUDAMED
- Basic UDI-DI
- 5414904273005XE EUDAMED
- Unit of Use DI
- 05414904041840 EUDAMED
- EMDN Code
- Z130106 DRY THERMAL PRINTER X-RAY FILMS 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
Drystar Dt 2 B 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 | 5414904273005XE | Class I | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (1)
- EUDAMED 69f9f872-fd60-47e6-87d7-c44f07971a72 61 fields · synced May 22, 2026