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SmartEIA Borrelia garinii VlsE IgG

by TestLine Clinical Diagnostics s.r.o.

Ref SK-BgGV96

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08595635305757 Basic UDI-DI 08595635305757UDI-DIDate24 Sep 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  • Withdrawn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
SmartEIA Borrelia garinii VlsE IgG
Model / Reference
SK-BgGV96
Primary DI / UDI-DI
08595635305757
Basic UDI-DI
B-08595635305757
EMDN Code
W0105010603 Lyme antibody igg
Device Class
Class IVD General
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001803

From the manufacturer

Manufacturer's product page: BLOT-LINE Borrelia garinii IgG

Other devices from TestLine Clinical Diagnostics s.r.o.

See all devices from TestLine Clinical Diagnostics s.r.o. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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