Identity
- Trade Name
- AllDx EUDAMED
- Device Name
- Hb Hemoglobin Meter EUDAMED
- Model / Reference
- M-HA EUDAMEDM-HA-0014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978467910054 EUDAMED
- Basic UDI-DI
- 697846791MHA000013R EUDAMED
- Direct Marketing DI
- 06978467910054 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
AllDx by Hangzhou Aokai Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697846791MHA000013R | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aokai Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048311
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED c0320ec4-ac01-43f6-be45-199062059798 61 fields · synced Jun 19, 2026