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TRIAMED, HALLUFIX, Hallux Valgus Orthosis
EUDAMEDClass I (EU MDR)
Ref SRT301RModel SRT 300
Identity
- Trade Name
- TRIAMED, HALLUFIX, Hallux Valgus Orthosis EUDAMED
- Device Name
- LOWER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 300 EUDAMEDSRT301R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760054369 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULINFDS EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
TRIAMED, HALLUFIX, Hallux Valgus Orthosis by Sc Triamed Srl — 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 | 594476005ORTMEMBRULINFDS | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (1)
- EUDAMED ea4d446e-f078-45c6-b687-b2e524d980ae 61 fields · synced Jul 20, 2026