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Mini Purifier

by Suzhou Acumen Biomedical Technology Co., LTD. 2 variants

Ref 290540Model P4

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697870466P45K Basic UDI-DI 06978704660001UDI-DIDate30 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Mini Purifier
Model / Reference
P4, 290540
Primary DI / UDI-DI
06978704660001
Basic UDI-DI
697870466P45K
Direct Marketing DI
06978704660001
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000038603
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No