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Autoblot WB Process Station
EUDAMEDClass A (EU MDR)
Ref H351000Model Auto 12 Dx
Identity
- Device Name
- Autoblot WB Process Station EUDAMED
- Model / Reference
- Auto 12 Dx EUDAMEDH351000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974149860099 EUDAMED
- Basic UDI-DI
- 697414986Auto12DxPQ EUDAMED
- Direct Marketing DI
- 06974149860099 EUDAMED
- EMDN Code
- W02050101 NUCLEIC ACID HYBRIDIZATION UNITS 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Autoblot WB Process Station by Aperbio Technologies (Suzhou) 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 | 697414986Auto12DxPQ | Class A | Active |
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Manufacturer
- Manufacturer
- Aperbio Technologies (Suzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000045149
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 2387c6a6-7a47-46d7-b930-04099ac51147 61 fields · synced Jul 12, 2026