Skip to content

HAA457T

by Biotem Co., Ltd.

Ref HAA457T

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800036235474 Basic UDI-DI 08800036235474UDI-DIDate1 Jun 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  • Withdrawn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

Model / Reference
HAA457T
Primary DI / UDI-DI
08800036235474
Basic UDI-DI
B-08800036235474
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000040891
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Biotem Co., ltd

See all devices from Biotem Co., ltd →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No