Identity
- Trade Name
- AllDx EUDAMED
- Device Name
- Cholesterol Control solution EUDAMED
- Model / Reference
- CS108 EUDAMEDCS108-0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978467910221 EUDAMED
- Basic UDI-DI
- B-06978467910221 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AllDx by Hangzhou Aokai Biotech Co., Ltd. — 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-06978467910221 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aokai Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048311
- Authorised Representative
- VidaQuick Biotech S.L. ES-AR-000048138
Sources (1)
- EUDAMED e9145bd7-fb31-42e8-b365-27465b2309cd 61 fields · synced Jun 18, 2026