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Urine Analyzer Cleaner I

by Qingdao Hightop Biotech Co., Ltd. EUDAMED

Active European Union EUDAMED: not on the EU market

Ref H4021

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69350916HT422MF Basic UDI-DIDate23 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Urine Analyzer Cleaner I
Model / Reference
H4021
Primary DI / UDI-DI
06935091676466, 06935091676473
Basic UDI-DI
69350916HT422MF
Direct Marketing DI
06935091676466
06935091676473
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000016890
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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