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Glycosylated Hemoglobin Hemolytic Agent

by Hotgen (Langfang) Biotech Co., Ltd. EUDAMED

Active European Union

Ref HGOTHER01Model Please see the IFU

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697541776017MX Basic UDI-DIDate21 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Please see the IFU, HGOTHER01
Primary DI / UDI-DI
06936700408508
Basic UDI-DI
697541776017MX
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018899
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hotgen (Langfang) Biotech Co., Ltd.

See all devices from Hotgen (Langfang) Biotech Co., Ltd. →

Properties

Show properties
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No