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Hygion

by Changshu Wilson Medical Devices Co., Ltd. 4 variants

Ref 614Model 2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500ml

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69723742202W4 Basic UDI-DI 06972374226147UDI-DIDate10 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500ml, 614
Primary DI / UDI-DI
06972374226147
Basic UDI-DI
69723742202W4
Direct Marketing DI
06972374226147
EMDN Code
A06030302 Hourly diuresis measurement sets
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000032020
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Changshu Wilson Medical Devices Co., Ltd.

See all devices from Changshu Wilson Medical Devices Co., Ltd. →

Properties

  • Sterile
  • Measuring Function

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No