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Fully automatic coagulation analyzer

by Jiangsu Hongen Medical Devices Co., Ltd. China EUDAMED

Ref H1201 Model H1201、H1202、H1203、H1204

EMDN W02029099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697949734FACA01RM Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fully automatic coagulation analyzer
Model / Reference
H1201、H1202、H1203、H1204, H1201
Primary DI / UDI-DI
06979497340071
Basic UDI-DI
697949734FACA01RM
EMDN Code
W02029099 Various hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051431
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Hongen Medical Devices Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED cb002c6a-b7f3-42b6-8150-693b81b66ab6 61 fields · synced 22 Oct 2026