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Cr Mm3.0 Mammo Set
EUDAMEDClass IIa (EU MDR)
Ref 10+9999912140 / ESWE4
by Agfa NV
Identity
- Trade Name
- CR MM3.0 MAMMO SET EUDAMED
- Device Name
- CR Set Mx.0 EUDAMED
- Model / Reference
- 10+9999912140 / ESWE4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05414904004456 EUDAMED
- Basic UDI-DI
- B-05414904004456 EUDAMED
- EMDN Code
- Z11060280 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cr Mm3.0 Mammo Set by Agfa NV — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05414904004456 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (1)
- EUDAMED 3150f172-b0b1-4ac2-b7ff-71a2805821ea 61 fields · synced Jun 20, 2026