Identity
- Trade Name
- AutoChem HBDH EUDAMED
- Model / Reference
- AutoChem analyzer EUDAMED360105HBD000S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942253005941 EUDAMED
- Basic UDI-DI
- 69422530000062NL EUDAMED
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
No
EUDAMED
AutoChem HBDH by Autobio Biochemistry Co., Ltd — Class B — 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 | 69422530000062NL | Class B | Active |
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Manufacturer
- Manufacturer
- Autobio Biochemistry Co., Ltd
- EUDAMED SRN
- CN-MF-000038143
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED ae890d4c-c95f-406c-9c49-6f880d364897 61 fields · synced Jun 19, 2026