Identity
- Trade Name
- SPOTCHEM II Fructosamine EUDAMED
- Device Name
- SPOTCHEM II Fructosamine EUDAMED
- Model / Reference
- 77413 EUDAMED77178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-77413J9 EUDAMEDD-77178JN EUDAMED
- Basic UDI-DI
- B-77413J9 EUDAMEDB-77178JN EUDAMED
- EMDN Code
- W01010210 FRUCTOSAMINE 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 Fructosamine 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-77413J9 | 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 (2)
- EUDAMED 6a230317-9626-49c1-b2ae-eec699a72574 61 fields · synced Jul 26, 2026
- EUDAMED 6ab8d590-88bb-4c1b-9d64-ce0d216c9154 61 fields · synced May 19, 2026