Identity
- Trade Name
- AllDx EUDAMED
- Device Name
- Blood Ketone Test Strips EUDAMED
- Model / Reference
- S103 EUDAMEDS103-0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978467910122 EUDAMED
- Basic UDI-DI
- B-06978467910122 EUDAMED
- EMDN Code
- W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) 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
Yes
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
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-06978467910122 | 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 b8de08da-bae1-4693-a2a0-5e0a75a0dc0d 61 fields · synced Jul 11, 2026