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Spotchem El (se-1520)
EUDAMEDClass IVD General (EU MDR)
Ref 47215Ref 47214Ref 107975
Identity
- Trade Name
- SPOTCHEM EL (SE-1520) EUDAMED
- Device Name
- SPOTCHEM EL (SE-1520) EUDAMED
- Model / Reference
- 47215 EUDAMED47214 EUDAMED107975 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47215H2 EUDAMEDD-47214GY EUDAMED04987486038009 EUDAMED
- Basic UDI-DI
- B-47215H2 EUDAMEDB-47214GY EUDAMED4987486BC0107975J3 EUDAMED
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Finland EUDAMEDItaly 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
Yes
EUDAMED
New Device
No
EUDAMED
Spotchem El (se-1520) 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-47215H2 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-47215H2 | Class IVD General | 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 (3)
- EUDAMED 4ed078a8-5d47-4ea8-b867-fe8167f2946d 61 fields · synced Jul 20, 2026
- EUDAMED 9778295b-82dc-4048-b393-bd22bd0ccb91 61 fields · synced May 17, 2026
- EUDAMED cf75aca3-353a-4f61-b187-6c9bc1e34670 61 fields · synced May 19, 2026