Identity
- Trade Name
- The Lab 004 (DB-3910) EUDAMED
- Device Name
- The Lab 004 (DB-3910) EUDAMED
- Model / Reference
- 105581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486028659 EUDAMEDD-105581MS EUDAMED
- Basic UDI-DI
- 4987486BC0105581GU EUDAMEDB-105581MS EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) 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 004 (DB-3910) 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 | 4987486BC0105581GU | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0105581GU | 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 73c7be22-1f3a-4312-b149-a0ad9ce98db6 61 fields · synced Jul 9, 2026
- EUDAMED 2f3f6349-03f0-46e7-aafb-88fb0db14456 61 fields · synced May 17, 2026