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vaginal speculum

by Changzhou Huankang Medical Device Co., Ltd. EUDAMED

Active European Union

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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06945934604853 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  • Withdrawn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-M single bag OPP INVISIO, HK-A06-M OPP INVISIO
Primary DI / UDI-DI
06945934604853
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 0a536464-627d-4fc0-a300-d9c9c31f53fd 61 fields · synced 24 Oct 2026