Identity
- Trade Name
- RFT EUDAMED
- Device Name
- HD 8CH WRIST ARRAY EUDAMED
- Model / Reference
- 10-F34722 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938146600225 EUDAMED
- Basic UDI-DI
- 69381466R10H10F347285 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 | 69381466R10H10F347285 | 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 d18835b1-2975-4319-8bab-825e05aad4af 61 fields · synced May 29, 2026