Identity
- Trade Name
- 31P/1H TxRx Flex Loop 7T EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Surface Coil EUDAMED31P/1H TxRx Flex Loop 7T FDA UDI
- Model / Reference
- 11371305 (01882) EUDAMED11371305 FDA UDI
- Description
- 31P/1H TxRx Flex Loop 7T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260487680157 EUDAMEDFDA UDI
- Basic UDI-DI
- 426048768FAMSurf_IIaKM EUDAMED
- Direct Marketing DI
- 04260487680157 EUDAMED
- 510(k) Number
- K183222 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
31P/1H TxRx Flex Loop 7T by Rapid Biomedical Gmbh — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426048768FAMSurf_IIaKM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
- EUDAMED SRN
- DE-MF-000008285
Sources (2)
- EUDAMED b2097974-4971-4e65-b355-8c1675d9f7f4 61 fields · synced Jun 18, 2026
- FDA UDI eba6cee6-7b68-4d73-bf37-6456689802db 35 fields · synced May 30, 2026