Identity
- Trade Name
- Preaccu EUDAMED
- Device Name
- Preaccu for Prenatal Screening EUDAMED
- Model / Reference
- 22010315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145513597 EUDAMED
- Basic UDI-DI
- 69471455Preaccu6W EUDAMED
- EMDN Code
- W0201020192 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Preaccu by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Class C — 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 | 69471455Preaccu6W | Class C | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005655
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8121c3d2-c948-4a1f-86ec-18247a7a4d65 61 fields · synced Oct 6, 2026