Identity
- Trade Name
- ELUENT 80A EUDAMED
- Device Name
- ELUENT 80A EUDAMED
- Model / Reference
- 71262 EUDAMED71274 EUDAMED42508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-71262H2 EUDAMEDD-71274H9 EUDAMEDD-42508GH EUDAMED
- Basic UDI-DI
- B-71262H2 EUDAMEDB-71274H9 EUDAMEDB-42508GH EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDItaly 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 80a 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-71262H2 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (3)
- EUDAMED aacf53c8-3611-4c76-820f-92641df231c8 61 fields · synced Jul 25, 2026
- EUDAMED 744aaa8b-85b8-401b-a5e0-02e2f797be33 61 fields · synced May 17, 2026
- EUDAMED d21e94f2-0f86-4208-928b-9066d9ce010f 61 fields · synced May 17, 2026