Identity
- Trade Name
- AutoChem PA EUDAMED
- Model / Reference
- AutoChem analyzer EUDAMED360101PA0000V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942253001226 EUDAMED
- Basic UDI-DI
- 69422530000013N7 EUDAMED
- EMDN Code
- W0102010305 PRE-ALBUMIN / TRANSTHYRETIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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 PA 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 | 69422530000013N7 | 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 ddadaf60-d6fc-4a6d-a0c1-d332324d5f65 61 fields · synced Jul 31, 2026