Skip to content

Anti-HBs Test

by Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. 8 variants

Ref RTHB02

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-08693285182695 Basic UDI-DI 08693285182695UDI-DIDate21 Apr 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  • Withdrawn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

Device Name
Anti-HBs Test
Model / Reference
RTHB02
Primary DI / UDI-DI
08693285182695
Basic UDI-DI
B-08693285182695
EMDN Code
W0105090299 Hepatitis viruses - rt & poc - other
Device Class
Class IVD Annex II List A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000028553

From the manufacturer

Manufacturer's product page: Anti-HBs TESTİ

Other devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.

See all devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. →

Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

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