Identity
- Trade Name
- ReLIA EUDAMED
- Device Name
- Homocysteine Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- RF16390-20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971354101931 EUDAMED
- Basic UDI-DI
- B-06971354101931 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE 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-06971354101931 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ReLIA Biotechnologies (Jiangsu), Inc.
- EUDAMED SRN
- CN-MF-000042042
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d200a42f-7f83-48fd-8599-2ea15eec3e23 61 fields · synced Jun 18, 2026