Identity
- Trade Name
- ReLIA EUDAMED
- Device Name
- Cardiac Troponin I (cTnI) Test (Colloidal Gold) EUDAMED
- Model / Reference
- RG16193-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971354101627 EUDAMED
- Basic UDI-DI
- B-06971354101627 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ReLIA by ReLIA Biotechnologies (Jiangsu), Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971354101627 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ReLIA Biotechnologies (Jiangsu), Inc.
- EUDAMED SRN
- CN-MF-000042042
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 18b62575-148f-4b5f-bc2b-e80e4a9e3a90 61 fields · synced Jun 18, 2026