Identity
- Trade Name
- The Lab 001 (CE-8810) EUDAMED
- Device Name
- The Lab 001 (CE-8810) EUDAMED
- Model / Reference
- 108223 EUDAMED106548 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486039044 EUDAMEDD-106548N3 EUDAMED
- Basic UDI-DI
- 4987486BC0108223GL EUDAMEDB-106548N3 EUDAMED
- EMDN Code
- W020105010202 CAPILLARY ELECTROPHORESIS SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland 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
The Lab 001 (CE-8810) 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 | 4987486BC0108223GL | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0108223GL | 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 996c3ccb-836a-48c5-aea4-b5fa7b3320f6 61 fields · synced Aug 4, 2026
- EUDAMED 0d339f51-9640-442c-835d-97d0870809b2 61 fields · synced May 17, 2026