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Optitrol VZV M

by LGC Clinical Diagnostics, Inc. 3 variants

Ref SR15078

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 Number0816784020124XU Basic UDI-DI 00850075956746UDI-DIDate24 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  • Withdrawn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
SR15078
Primary DI / UDI-DI
00850075956746
Basic UDI-DI
0816784020124XU
EMDN Code
W0105080804 Other virology controls - inf.imm.
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000016356
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from LGC Clinical Diagnostics, Inc.

See all devices from LGC Clinical Diagnostics, Inc. →

Properties

  • Professional Testing
  • New Device

Other properties (9)

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