Identity
- Trade Name
- M3DP, Mammo 3D Performance Kit EUDAMED
- Device Name
- M3DP Mammo 3D Performance Kit EUDAMED
- Model / Reference
- M3DP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060608881482 EUDAMED
- Basic UDI-DI
- 506060888M3DPPH57 EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
M3DP, Mammo 3D Performance Kit by Sun Nuclear Corporation — 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 | 506060888M3DPPH57 | Class I | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000021541
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (1)
- EUDAMED 958a481b-84a3-4e2f-8b34-d1f712b04485 61 fields · synced Jul 11, 2026