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Rft
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5630000-2/5630000-3/5630000-4Model 10-F24260/10-F24261/10-F24262
Identity
- Trade Name
- RFT EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 8ch Flex 70 Array/8ch Flex 50 Array/8ch Flex 40 Array EUDAMED1.5T 8ch Flex 70 Array (A-port) FDA UDI
- Model / Reference
- 10-F24260/10-F24261/10-F24262 EUDAMED5630000-2/5630000-3/5630000-4 EUDAMED10-F24260 FDA UDI
- Description
- 1.5T 8ch Flex 70 Array (A-port) FDA UDI
Identifiers
- Catalog Number
- M7006PB FDA UDI
- Primary DI / UDI-DI
- 06938146600034 EUDAMEDFDA UDI
- Basic UDI-DI
- 69381466R03P10F242TFH EUDAMED
- Unit of Use DI
- 06938146600041 EUDAMED
- 510(k) Number
- K172222 FDA UDI
- 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 | 69381466R03P10F242TFH | 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 4d2e595b-9e00-461b-8c17-b63073bc70b4 61 fields · synced Jul 12, 2026
- FDA UDI 6c6c801c-a0ad-40d5-b8f7-c59b53bdd185 35 fields · synced May 30, 2026