Identity
- Trade Name
- SPOTCHEM D-02 (SD-4810) EUDAMED
- Device Name
- SPOTCHEM D-02 (SD-4810) EUDAMED
- Model / Reference
- 107504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486034575 EUDAMED
- Basic UDI-DI
- 4987486BC0107504GQ EUDAMED
- EMDN Code
- W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h) EUDAMED
Classification
- Device Class
- Class A 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
Spotchem D-02 (sd-4810) by ARKRAY Factory, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987486BC0107504GQ | Class A | 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 (1)
- EUDAMED 880ad2dc-d347-41eb-aff6-ed9676946548 61 fields · synced Jun 18, 2026