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Drystar Dt 5.000i Mammo
EUDAMEDClass I (EU MDR)
Ref EZ5K3Ref EZ5L5Ref EZ5J1
by Agfa NV
Identity
- Trade Name
- DRYSTAR DT 5.000I MAMMO EUDAMED
- Device Name
- Hard Copy Film EUDAMED
- Model / Reference
- EZ5K3 EUDAMEDEZ5L5 EUDAMEDEZ5J1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904011966 EUDAMED05414904011959 EUDAMED05414904011973 EUDAMED
- Basic UDI-DI
- 5414904273005XE EUDAMED
- Unit of Use DI
- 05414904223314 EUDAMED05414904223093 EUDAMED05414904223338 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 5.000i Mammo 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 (3)
- EUDAMED 3560197f-fe7b-4304-b566-a427e05c216f 61 fields · synced Aug 2, 2026
- EUDAMED ca4158eb-42bc-4707-8ab0-212155d2eec0 61 fields · synced May 18, 2026
- EUDAMED f69af71a-c770-4c11-87b9-ae126f3fb721 61 fields · synced May 18, 2026