Identity
- Trade Name
- ADAMS A1c (HA-8180T) EUDAMED
- Device Name
- ADAMS A1c (HA-8180T) EUDAMED
- Model / Reference
- 107361 EUDAMED34116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486033622 EUDAMEDD-34116FX EUDAMED
- Basic UDI-DI
- 4987486BC0107361GS EUDAMEDB-34116FX EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDItaly 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
New Device
No
EUDAMED
ADAMS A1c (HA-8180T) by ARKRAY Factory, Inc. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4987486BC0107361GS | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0107361GS | Class A | 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 (2)
- EUDAMED 8c569559-445f-4e8f-a6e2-716d8ec12ead 61 fields · synced Jul 17, 2026
- EUDAMED a7b737f6-2db9-4ddb-81ce-1b144e1745c7 61 fields · synced May 18, 2026