Identity
- Trade Name
- SPOTCHEM II Amy-wide EUDAMED
- Device Name
- SPOTCHEM II Amy-wide EUDAMED
- Model / Reference
- 100170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100170KW EUDAMED
- Basic UDI-DI
- B-100170KW EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SPOTCHEM II Amy-wide by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-100170KW | 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 (1)
- EUDAMED f7354991-4499-45ae-8029-02830952bf93 61 fields · synced Jun 18, 2026