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TRIAMED, ARMFIX, Shoulder orthosis
EUDAMEDClass I (EU MDR)
Ref SRT218M1Model SRT 200
Identity
- Trade Name
- TRIAMED, ARMFIX, Shoulder orthosis EUDAMED
- Device Name
- UPPER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 200 EUDAMEDSRT218M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760053447 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULSUPGM EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES 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, ARMFIX, Shoulder 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 | 594476005ORTMEMBRULSUPGM | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (1)
- EUDAMED b0dbbcbc-2421-4098-8450-b836dcd1c81c 61 fields · synced Jun 19, 2026