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VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit

by Certest Biotec S.L. 24 variants

Ref VS-HHZ136E

Active European Union

CE IVDR

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/IVDR Number84354402_MDXIMMUN_HHZ7D Basic UDI-DI 08435440228950UDI-DIDate21 Jul 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
VS-HHZ136E
Primary DI / UDI-DI
08435440228950
Basic UDI-DI
84354402_MDXIMMUN_HHZ7D
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class C
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000002193

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No