← Back to catalogue
Rft
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10-F34744Ref 5630000-10Model 10-F24263Ref 10-F35782Ref 10-F34742Ref 10-F34743Ref 5630000-5/5630000-6/5630000-7Model 10-F25061/10-F25062/10-F25063
Identity
- Trade Name
- RFT EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GEM FLEX COIL 16-L ARRAY, 3.0T RECEIVE ONLY EUDAMED8ch Flex Suite General Purpose Strap EUDAMEDGEM FLEX COIL 16-S ARRAY, 1.5T RECEIVE ONLY EUDAMEDGEM FLEX COIL 16-M ARRAY, 3.0T RECEIVE ONLY EUDAMEDGEM FLEX COIL 16-S ARRAY, 3.0T RECEIVE ONLY EUDAMED8ch Flex 70 Array/8ch Flex 50 Array/8ch Flex 40 Array EUDAMED8ch Flex 70 Array FDA UDI
- Model / Reference
- 10-F34744 EUDAMED10-F24263 EUDAMED5630000-10 EUDAMED10-F35782 EUDAMED10-F34742 EUDAMED10-F34743 EUDAMED10-F25061/10-F25062/10-F25063 EUDAMED5630000-5/5630000-6/5630000-7 EUDAMED10-F25061 FDA UDI
- Description
- 8ch Flex 70 Array FDA UDI
Identifiers
- Catalog Number
- M7006PE FDA UDI
- Primary DI / UDI-DI
- 06938146600232 EUDAMED06938146600157 EUDAMED06938146600195 EUDAMED06938146600249 EUDAMED06938146600256 EUDAMED06938146600065 EUDAMEDFDA UDI
- Basic UDI-DI
- 69381466FLX10F4744L7F EUDAMED69381466SPP10F4263XN EUDAMED69381466GEM10F5782LSU EUDAMED69381466FLX10F4742NA EUDAMED69381466FLX10F4743NC EUDAMED69381466R04P10F250TG7 EUDAMED
- Unit of Use DI
- 06938146600089 EUDAMED
- 510(k) Number
- K200836 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
EUDAMEDEUDAMED
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
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 | 69381466FLX10F4744L7F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen RF Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000010149
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (7)
- EUDAMED c2960780-1460-40e9-9f31-102a2268f8e3 61 fields · synced Jul 27, 2026
- EUDAMED bd21d1ca-89d2-4937-8f7b-97af0a5420f6 61 fields · synced May 17, 2026
- EUDAMED d1ba5e54-acfd-4f0b-a606-a5294628b609 61 fields · synced May 17, 2026
- EUDAMED 091417d3-d268-4ee0-94b8-9a2b8a9e100c 61 fields · synced May 18, 2026
- EUDAMED 46faf45a-8fc2-49c9-ae22-5960babe32db 61 fields · synced May 19, 2026
- EUDAMED 90aaac7e-b3ba-426a-8c7d-4e992a28d276 61 fields · synced May 19, 2026
- FDA UDI 31f91a30-adeb-475f-b55f-676a3f5bfd95 35 fields · synced May 30, 2026