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PreClean
EUDAMEDClass A (EU MDR)
Ref 0320507502Model 2×2 L，4×2 L，2×800 mL，4×800 mLRef 0320507503Ref 0320507504
Identity
- Trade Name
- PreClean EUDAMED
- Device Name
- PreClean EUDAMED
- Model / Reference
- 2×2 L，4×2 L，2×800 mL，4×800 mL EUDAMED0320507502 EUDAMED0320507503 EUDAMED0320507504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139070895 EUDAMED06978139070901 EUDAMED06978139070932 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 (3)
- EUDAMED baeb6684-2f9d-4a31-b11b-f9bbc1fb7442 61 fields · synced Aug 1, 2026
- EUDAMED 0aed3074-13cb-43cb-a6e6-fc592efefe58 61 fields · synced May 18, 2026
- EUDAMED 872fd626-6eb6-45f7-bcf7-04b6687c069f 61 fields · synced May 18, 2026