Skip to content

Leetrac

by B&L Biotech 2 variants

Ref LeetracModel LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR, LTRWT, LTRSS, LTNWT

Active European Union

CE MDR CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number88000191LEETRACK4 Basic UDI-DI Date13 Apr 2024RegisteredStatusActive
European UnionCE/MDR Number88000191LEETRACK4 Basic UDI-DI Date13 Apr 2024RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference
LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR, Leetrac, LTRWT, LTRSS, LTNWT
Primary DI / UDI-DI
08800019110910, 08800019110927, 08800019110996
Basic UDI-DI
88000191LEETRACK4, B-08800019110910, B-08800019110927, B-08800019110996
EMDN Code
L150201 Dental retractors, reusable
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from B&L Biotech

  • Sprds

    Class IIa

  • Sprdn

    Class IIa

  • Leetrac

    Class I

  • BSN2123

    Class IIa

  • BMN2425

    Class IIa

  • BSN2225

    Class IIa

See all devices from B&L Biotech →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No