Identity
- Trade Name
- ADAMS A1c (HA-8190V) EUDAMED
- Device Name
- ADAMS A1c (HA-8190V) EUDAMED
- Model / Reference
- 106341 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-106341MB EUDAMED
- Basic UDI-DI
- B-106341MB EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
ADAMS A1c (HA-8190V) 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-106341MB | 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 (1)
- EUDAMED ff784c7c-b945-4c03-a029-6e935ee5acf5 61 fields · synced May 23, 2026