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IS-II active Fixture_set

by Neobiotech Co., Ltd. EUDAMED

Active European Union

Ref BIS5006A

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809276763853 Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Model / Reference
BIS5006A
Primary DI / UDI-DI
08809276763853
Basic UDI-DI
B-08809276763853
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000016946
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: IS-III Active>

Other devices from Neobiotech Co., Ltd.

See all devices from Neobiotech Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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