Identity
- Trade Name
- SpotChem EL 2 (SE-1530) EUDAMED
- Device Name
- SpotChem EL 2 (SE-1530) EUDAMED
- Model / Reference
- 111113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486051367 EUDAMED
- Basic UDI-DI
- 4987486BC0110048FD EUDAMED
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS 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 EL 2 (SE-1530) 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 | 4987486BC0110048FD | 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 (1)
- EUDAMED 3d0424a9-688f-4e5f-a6e5-9774fd4262e1 61 fields · synced Jul 9, 2026