Identity
- Trade Name
- ELUENT 80CV EUDAMED
- Device Name
- ELUENT 80CV EUDAMED
- Model / Reference
- 71279 EUDAMED71278 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-71279HK EUDAMEDD-71278HH EUDAMED
- Basic UDI-DI
- B-71279HK EUDAMEDB-71278HH EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Eluent 80cv by ARKRAY Factory, 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-71279HK | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (2)
- EUDAMED e63a5e31-edde-4962-ab42-71fb0beb28dd 61 fields · synced Aug 3, 2026
- EUDAMED 0966098b-c9ad-4060-8d04-6a4b5e89f0af 61 fields · synced May 18, 2026