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TRIAMED, ELBI PREMIUM PLUS, Epicondilitis brace
EUDAMEDClass I (EU MDR)
Ref SRT216M2Model SRT200Ref SRT216M1Ref SRT216M6
Identity
- Trade Name
- TRIAMED, ELBI PREMIUM PLUS, Epicondilitis brace EUDAMED
- Device Name
- UPPER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT200 EUDAMEDSRT216M2 EUDAMEDSRT216M1 EUDAMEDSRT216M6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944757805875 EUDAMED05944757805851 EUDAMED05944757805882 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 PREMIUM 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 (3)
- EUDAMED 7ff01b18-2de0-44f2-b976-b7e60979f6bb 61 fields · synced Jul 24, 2026
- EUDAMED 6452f50d-f4ad-4fe5-b8d9-28bcdea8cff9 61 fields · synced May 17, 2026
- EUDAMED f2644e9a-a85a-4263-a23e-d7cfda6f54b9 61 fields · synced May 17, 2026