Identity
- Trade Name
- COLUMN UNIT 90 EUDAMED
- Device Name
- COLUMN UNIT 90 EUDAMED
- Model / Reference
- 105723 EUDAMED107369 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-105723MN EUDAMED04987486033684 EUDAMED
- Basic UDI-DI
- B-105723MN EUDAMED4987486BC0107369HA EUDAMED
- EMDN Code
- W0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Austria EUDAMEDIreland 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
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Column Unit 90 by ARKRAY Factory, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-105723MN | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-105723MN | 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 1a8a80f8-7155-4284-b1aa-02c22a38c085 61 fields · synced Aug 4, 2026
- EUDAMED 2d70c929-7993-451f-8eaa-2a4779e4b138 61 fields · synced May 18, 2026