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SPOTCHEM II HDL-Cholesterol (Direct Method)
EUDAMEDClass IVD General (EU MDR)
Ref 77181Ref 77416
Identity
- Trade Name
- SPOTCHEM II HDL-Cholesterol (Direct Method) EUDAMED
- Device Name
- SPOTCHEM II HDL-Cholesterol (Direct Method) EUDAMED
- Model / Reference
- 77181 EUDAMED77416 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-77181JB EUDAMEDD-77416JF EUDAMED
- Basic UDI-DI
- B-77181JB EUDAMEDB-77416JF EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDItaly 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 HDL-Cholesterol (Direct Method) 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-77181JB | 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 061bfeba-14ee-4516-9d8d-0e4f8b5be0ac 61 fields · synced Jul 26, 2026
- EUDAMED ca775365-7dfa-4095-a4ba-1a78aa9b229c 61 fields · synced May 18, 2026