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Vazyme Hybrid System

by Nanjing Vazyme Medical Technology Co., Ltd. China EUDAMED

Ref Hybrid-I-M EMDN W02050116

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6973315739436B8 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
Hybrid-I-M
Primary DI / UDI-DI
06973315739436
Basic UDI-DI
6973315739436B8
Direct Marketing DI
06973315739436
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031032
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Nanjing Vazyme Medical Technology Co., Ltd.

See all devices from Nanjing Vazyme Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 06973315739436|6973315739436B8 61 fields · synced 25 Oct 2026