Identity
- Trade Name
- RFT EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 8CH FOOT ANKLE COIL EUDAMED3.0T 8ch Foot Ankle Coil FDA UDI
- Model / Reference
- 10-F21457 EUDAMEDFDA UDI5567773-2 EUDAMED
- Description
- 3.0T 8ch Foot Ankle Coil FDA UDI
Identifiers
- Catalog Number
- M7001KM FDA UDI
- Primary DI / UDI-DI
- 06938146600010 EUDAMEDFDA UDI
- Basic UDI-DI
- 69381466R01K10F214TAT EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I 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
No
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
Yes
FDA UDI
MR Safe FDA UDI
Rft by Shenzhen RF Tech Co., Ltd. — Class I — 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 | 69381466R01K10F214TAT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen RF Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000010149
- Authorised Representative
- OSMUNDA Medical Technology Service GmbH DE-AR-000009285
Sources (2)
- EUDAMED 44fb7d14-5afa-43ea-8cdc-d16bbdde16ff 61 fields · synced Aug 3, 2026
- FDA UDI ed277aac-8c1e-4ed1-bfb9-3425fc1e4e44 35 fields · synced May 30, 2026