Identity
- Trade Name
- AutoChem Wash B EUDAMED
- Device Name
- AutoChem Wash B EUDAMEDAutoChem Wash R EUDAMED
- Model / Reference
- 360115XYB0001 EUDAMED360115XYR0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942253020630 EUDAMED06942253020692 EUDAMED
- Basic UDI-DI
- 69422530000128NR EUDAMED69422530000130NC 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 B 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 | 69422530000128NR | 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 (2)
- EUDAMED 7e8104e9-770f-40d0-adc1-8c7985c3b096 61 fields · synced Jul 28, 2026
- EUDAMED f7a728c5-25e0-4edc-a168-5d65e2ec0911 61 fields · synced May 18, 2026