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AutoChem Wash A
EUDAMEDClass A (EU MDR)
Ref 360115XYA0001Model Automatic Chemistry Analyzer
Identity
- Trade Name
- AutoChem Wash A EUDAMED
- Device Name
- AutoChem Wash A EUDAMED
- Model / Reference
- Automatic Chemistry Analyzer EUDAMED360115XYA0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942253020593 EUDAMED
- Basic UDI-DI
- 69422530000127NP EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
AutoChem Wash A by Autobio Biochemistry 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 | 69422530000127NP | Class A | 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 cd9c083d-0b9d-4e56-a790-bfba95ce7201 61 fields · synced Jun 19, 2026