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Vaginitis Multi-Test Kit (Dry Chemoenzymatic Method)

by AVE Science & Technology Co., Ltd.

Model Package 1: AVE-1A, 1B, 1C, 1D, 1E, 1F, 1G, 2A, 3A, 4A, 4B, 5A, 5B, 5C, 5D, 5E, 6A, 6B, 7A, 8A, 8B, 9A, 10A, 10B, 11A; Package 2: AVE-1A, 1B, 1C, 1D, 1E, 1F, 1G, 2A, 3A, 4A, 4B, 5A, 5B, 5C, 5D, 5E, 6A, 6B, 7A, 8A, 8B, 9A, 10A, 10B, 11A

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-06956013952154 Basic UDI-DI 06956013952154UDI-DIDate26 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Vaginitis Multi-Test Kit (Dry Chemoenzymatic Method)
Model / Reference
Package 1: AVE-1A, 1B, 1C, 1D, 1E, 1F, 1G, 2A, 3A, 4A, 4B, 5A, 5B, 5C, 5D, 5E, 6A, 6B, 7A, 8A, 8B, 9A, 10A, 10B, 11A, Package 2: AVE-1A
Primary DI / UDI-DI
06956013952154
Basic UDI-DI
B-06956013952154
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031214
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ave Science & Technology Co., Ltd

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No