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TRIAMED, SINTEX, Arm support
EUDAMEDClass I (EU MDR)
Ref SRT217Model SRT 200Ref SRT217M4Ref SRT217M2Ref SRT217M1
Identity
- Trade Name
- TRIAMED, SINTEX, Arm support EUDAMEDTRIAMED, SINTEX, Arm support EUDAMED
- Device Name
- UPPER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 200 EUDAMEDSRT217 EUDAMEDSRT217M4 EUDAMEDSRT217M2 EUDAMEDSRT217M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760050446 EUDAMED05944760050453 EUDAMED05944760050439 EUDAMED05944760050422 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULSUPGM EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - 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, SINTEX, Arm support 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 (4)
- EUDAMED 025834be-18b5-4431-82ed-f444f15628b6 61 fields · synced Jul 23, 2026
- EUDAMED f20b4c77-1648-40ea-beb8-1e45c34e5a51 61 fields · synced May 17, 2026
- EUDAMED b414f4b3-461d-4192-9766-aae309e4e1d1 61 fields · synced May 18, 2026
- EUDAMED af8f9810-24e7-48d3-bf17-d52aa8af7ee5 61 fields · synced May 18, 2026