Identity
- Trade Name
- ²³Na / ¹H Breast Array EUDAMED
- Device Name
- Breast Coil EUDAMED
- Model / Reference
- 01901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260487680669 EUDAMED
- Basic UDI-DI
- 426048768FAMBreast_IIaCB EUDAMED
- Direct Marketing DI
- 04260487680669 EUDAMED
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
²³Na / ¹H Breast Array by Rapid Biomedical Gmbh — Class IIa — 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 | 426048768FAMBreast_IIaCB | Class IIa | Active |
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Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
- EUDAMED SRN
- DE-MF-000008285
Sources (1)
- EUDAMED ac1c5d6e-d73d-4e22-a5fa-c152e33e44bc 61 fields · synced Jun 17, 2026