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vaginal speculum

by Changzhou Huankang Medical Device Co., Ltd. EUDAMED

Active European Union

Ref HK-A06-XS OPP INVISIOModel HK-A06-XS single bag OPP INVISIO

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06945934604877 Basic UDI-DIDate17 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
HK-A06-XS single bag OPP INVISIO, HK-A06-XS OPP INVISIO
Primary DI / UDI-DI
06945934604877
Basic UDI-DI
B-06945934604877
EMDN Code
U089006 Vaginal speculum, single-use
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000009030
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changzhou Huankang Medical Device Co., Ltd.

See all devices from Changzhou Huankang Medical Device Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No