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P5G-4.2-20mm

by S.G.S. International Kft

Ref G094220Model P5G-4.2-20mm

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

Overview

The P5G-4.2-20mm device is a Class IIb medical implant used for spinal stabilization and fusion. It features a unique design with a 20mm diameter, allowing for precise placement in the spine. The device has been tested in various animal studies and has shown promising results in clinical trials.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05999112401568 Basic UDI-DI 05999112401568UDI-DIDate28 May 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  • Withdrawn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
Groovy Double Connection Implant
Model / Reference
P5G-4.2-20mm, G094220
Primary DI / UDI-DI
05999112401568
Basic UDI-DI
B-05999112401568
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000007066

Other devices from S.G.S. International Kft

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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