Identity
- Trade Name
- 2H/1H Head Coil EUDAMED
- Device Name
- Head Coil EUDAMED
- Model / Reference
- 02298 EUDAMED02228 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260487681338 EUDAMED04260487681192 EUDAMED
- Basic UDI-DI
- 426048768FAMHead_IIaUW EUDAMED
- Direct Marketing DI
- 04260487681338 EUDAMED04260487681192 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
2H/1H Head Coil 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 | 426048768FAMHead_IIaUW | Class IIa | Active |
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Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
- EUDAMED SRN
- DE-MF-000008285
Sources (2)
- EUDAMED 4bf49c25-a7c3-40ba-8914-4f2fbadba0f2 61 fields · synced Jul 20, 2026
- EUDAMED 48225de2-dbce-4574-9b25-231d3591247c 61 fields · synced May 17, 2026