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TRIAMED, ELBI PREMIUS PLUS, Epicondilitis brace
EUDAMEDClass I (EU MDR)
Ref SRT216M5Model SRT200
Identity
- Trade Name
- TRIAMED, ELBI PREMIUS PLUS, Epicondilitis brace EUDAMED
- Device Name
- UPPER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT200 EUDAMEDSRT216M5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944757805899 EUDAMED
- Basic UDI-DI
- 59447578ORTMEMBRULSUPQS EUDAMED
- EMDN Code
- Y060615 ELBOW 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, ELBI PREMIUS PLUS, Epicondilitis brace 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 | 59447578ORTMEMBRULSUPQS | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (1)
- EUDAMED 291e4e5e-6cc1-41c7-9d9d-13caa1e4a82d 61 fields · synced Jun 18, 2026