Identity
- Device Name
- orthotics EUDAMED
- Model / Reference
- FYTC4XX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977568950044 EUDAMED
- Basic UDI-DI
- 6977568950044KQ EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
orthotics by Beijing Fuyutiancheng Prosthetics&Orthotics Company 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 | 6977568950044KQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000042807
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 6174b0fc-8c3e-4d18-a545-26d04defb40a 61 fields · synced Oct 6, 2026