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Guide Surgical Kit

by Bio3 Implants GmbH EUDAMED

Active European Union

Ref GSKModel Non-Sterile Set of Instruments

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4060475BIO3GSKKITER Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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
Non-Sterile Set of Instruments, GSK
Primary DI / UDI-DI
04060475004084
Basic UDI-DI
4060475BIO3GSKKITER
EMDN Code
P01020180 Dental implants - accessories
Device Class
Class IIa
Medical Purpose
The surgical guide is intended for use in assisting placement of dental implants.

Manufacturer details

EUDAMED SRN
DE-PR-000031675

From the manufacturer

Manufacturer's product page: View catalog

Other devices from Bio3 Implants GmbH

See all devices from Bio3 Implants GmbH →

Properties

Other properties (1)

  • Sterile: No