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vaginal speculum

by Changzhou Huankang Medical Device Co., Ltd. 83 variants

Ref HK-A04-S single bag OPP Medplus

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06945934601937 Basic UDI-DI 06945934601937UDI-DIDate20 Apr 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
HK-A04-S single bag OPP Medplus
Primary DI / UDI-DI
06945934601937
Basic UDI-DI
B-06945934601937
EMDN Code
U089006 Vaginal speculum, single-use
Device Class
Class I
EU market of registration
Czechia

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