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AMA304850

by Biotem Co., Ltd. South Korea EUDAMED

Ref AMA304850

EMDN P01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800036211867 Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AMA304850
Primary DI / UDI-DI
08800036211867
Basic UDI-DI
B-08800036211867
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED d833d193-7546-458a-b565-011e5a7015f0 61 fields · synced 24 Oct 2026