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PreClean
EUDAMEDClass A (EU MDR)
Ref 0320507501Model 2×2 L，4×2 L，2×800 mL，4×800 mL
Identity
- Trade Name
- PreClean EUDAMED
- Device Name
- PreClean EUDAMED
- Model / Reference
- 2×2 L，4×2 L，2×800 mL，4×800 mL EUDAMED0320507501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689537 EUDAMED
- Basic UDI-DI
- 69703416803205071JJ EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
PreClean by Shenzhen Lifotronic Technology 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 | 69703416803205071JJ | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED acc15d8f-447f-435a-8e5e-bf1955616276 61 fields · synced Jun 19, 2026