Identity
- Trade Name
- SPOTCHEM II PANEL-1 EUDAMED
- Device Name
- SPOTCHEM II PANEL-1 EUDAMED
- Model / Reference
- 77419 EUDAMED77184 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-77419JM EUDAMEDD-77184JH EUDAMED
- Basic UDI-DI
- B-77419JM EUDAMEDB-77184JH EUDAMED
- EMDN Code
- W01010404 MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDFinland 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 Panel-1 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-77419JM | Class IVD General | 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 (2)
- EUDAMED cc8e16dd-f634-4287-b1db-292d3661156e 61 fields · synced Jul 15, 2026
- EUDAMED 504ce592-3a55-45d5-9c19-ac43c19d5b82 61 fields · synced May 18, 2026