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Disposable Uterine Manipulator and Vaginal Delineators

by Surgitools（Shanghai）Medical Instruments Co., Ltd. 8 variants

Ref UCM-1820Model UCM-1810,UCM-1820,SUMC,CGD,CBD,CWD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697144135SUMCNE Basic UDI-DI 06971441351324UDI-DIDate5 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Disposable Uterine Manipulator and Vaginal Delineators
Model / Reference
UCM-1810, UCM-1820, SUMC, CGD, CBD, CWD
Primary DI / UDI-DI
06971441351324
Basic UDI-DI
697144135SUMCNE
Direct Marketing DI
06971441351324
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000055047
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Surgitools（Shanghai）Medical Instruments Co., Ltd.

See all devices from Surgitools（Shanghai）Medical Instruments Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No