Skip to content

Bio-Tack S

by Biocetec Co., Ltd. 192 variants

Ref BTH1808S

Active European Union

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-BTH1808SCH Basic UDI-DI D-BTH1808SCHUDI-DIDate8 Oct 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Orthodontic Mini Screw
Model / Reference
BTH1808S
Primary DI / UDI-DI
D-BTH1808SCH
Basic UDI-DI
B-BTH1808SCH
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000045343
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Biocetec Co., Ltd.

See all devices from Biocetec Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: 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