Skip to content

Automatic Chemiluminescence Immunoassay Analyzer

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

Active European Union

Ref HGMQ60 smartModel MQ60 smart

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697541776MS5F 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  • Withdrawn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
MQ60 smart, HGMQ60 smart
Primary DI / UDI-DI
06975417765009
Basic UDI-DI
697541776MS5F
EMDN Code
W02069099 Various sample processing instruments - 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
  • 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