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Fully Auto Glycated Hemoglobin Analyzer

by Shenzhen Xilaiheng Medical Electronics Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref /Model H600, H600Plus, H650, H650Plus

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697520038600YQ3N Basic UDI-DIDate18 Aug 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Fully Auto Glycated Hemoglobin Analyzer
Model / Reference
H600, H600Plus, H650, H650Plus, /
Primary DI / UDI-DI
06975200381553
Basic UDI-DI
697520038600YQ3N
Direct Marketing DI
06975200381553
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000047090
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Xilaiheng Medical Electronics Co., Ltd.

Properties

  • Surgical Instrument

Other properties (10)

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