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Glycated Hemoglobin Analyzer HAM111

by Beijing Lepu Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref JY45HAM111Model HAM111

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692180764007FH Basic UDI-DIDate10 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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

Model / Reference
HAM111, JY45HAM111
Primary DI / UDI-DI
06921807611456
Basic UDI-DI
692180764007FH
Direct Marketing DI
06921807611456
EMDN Code
W02029099 Various hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000033011
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Beijing Lepu Medical Technology Co., Ltd.

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Properties

  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument

Other properties (8)

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