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H2

by Graphite Medical EUDAMED

Active European Union

Ref H2 UE, H2 XXL, H2 S, H2 XS, H2 L, H2 M, H2 XL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number36156H22D Basic UDI-DIDate9 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
H2
Model / Reference
H2 UE, H2 XXL, H2 S, H2 XS, H2 L, H2 M, H2 XL
Primary DI / UDI-DI
03615650002594, 03615650002624, 03615650002570, 03615650002617, 03615650001887, 03615650002563, 03615650002600
Basic UDI-DI
36156H22D
EMDN Code
Y060624 Shoulder-elbow 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

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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