Identity
- Trade Name
- Drystar 5301 EUDAMED
- Device Name
- Printer 5366 EUDAMED
- Model / Reference
- 57KAX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904211885 EUDAMED
- Basic UDI-DI
- 5414904272763YQ EUDAMED
- EMDN Code
- Z110706 VIDEO OR DIGITAL BIOIMAGING PLAYERS 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 5301 by Agfa NV — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: DRYSTAR 5301
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 | 5414904272763YQ | Class I | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (1)
- EUDAMED a9231bd5-423c-4d4b-ace1-f58d5af390ac 61 fields · synced Jun 19, 2026