Identity
- Trade Name
- 1H Breast Array EUDAMED
- Device Name
- Breast Coil EUDAMED
- Model / Reference
- 01514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260487680768 EUDAMED
- Basic UDI-DI
- 426048768FAMBreast_IBJ EUDAMED
- Direct Marketing DI
- 04260487680768 EUDAMED
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES 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
1H Breast Array by Rapid Biomedical Gmbh — 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 | 426048768FAMBreast_IBJ | Class I | Active |
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Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
- EUDAMED SRN
- DE-MF-000008285
Sources (1)
- EUDAMED 5bb8a842-f5a1-48a0-996c-21ca4f56f34f 61 fields · synced Jun 19, 2026