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by Zhangjiagang Shengang Medical Products Co., Ltd. China EUDAMED

Ref SG1021Model UM-I-2020,UM-I-2050,UM-I-2550,UM-I-2640,UM-I-2650,UM-II-2540,UM-II-2640,UM-III-2540,UM-III-2640,UM-IV-2050,UM-IV-3050,

EMDN V030206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69382140104-UMW8 Basic UDI-DIDate20 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Urine Meter
Model / Reference
UM-I-2020, UM-I-2050, UM-I-2550, UM-I-2640, UM-I-2650, UM-II-2540, UM-II-2640, UM-III-2540, UM-III-2640, UM-IV-2050, UM-IV-3050, SG1021
Primary DI / UDI-DI
06938214010239
Basic UDI-DI
69382140104-UMW8
EMDN Code
V030206 Urology measurement devices not included in other classes
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011905
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Zhangjiagang Shengang Medical Products Co., Ltd.

  • many

    Class IIa
  • many

    Class I
  • many

    Class IIa
  • many

    Class I
  • many

    Class I
  • many

    Class IIa

See all devices from Zhangjiagang Shengang Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED f7a83a61-3731-42bc-917e-90bb7851a6e6 61 fields · synced 22 Oct 2026