Identity
- Trade Name
- RFT EUDAMED
- Device Name
- GEM FLEX COIL 16-M ARRAY, 1.5T RECEIVE ONLY EUDAMED
- Model / Reference
- 10-F35781 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938146600188 EUDAMED
- Basic UDI-DI
- 69381466GEM10F5781MST EUDAMED
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Rft by Shenzhen RF Tech Co., Ltd. — Class I — 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 | 69381466GEM10F5781MST | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen RF Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000010149
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 9c6799e7-b7da-4975-a192-fe63707f650e 61 fields · synced May 22, 2026