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G1 Scgel

by Graphite Medical EUDAMED

Active European Union

Ref SCGEL 50 L, SCGEL 35 XL, SCGEL 50 XL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number36156G1SCGEL6H Basic UDI-DIDate9 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
G1 Scgel
Model / Reference
SCGEL 50 L, SCGEL 35 XL, SCGEL 50 XL
Primary DI / UDI-DI
03615650000385, 03615650001344, 03615650000392
Basic UDI-DI
36156G1SCGEL6H
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002504

Other devices from Graphite Medical

See all devices from Graphite Medical →

Properties

Show properties
  • Contains Latex
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No