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HPV Cocktail Broad Spectrum (HPV-1, 6, 11, 16, 18 and 31)

by Biocare Medical 2 variants

Ref ACI177CK

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 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/IVDD NumberB-00847627031563 Basic UDI-DI 00847627031563UDI-DIDate3 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
ACI177CK
Primary DI / UDI-DI
00847627031563
Basic UDI-DI
B-00847627031563
EMDN Code
W0105041099 Hpv reagents - other
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000034581
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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