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H3

by Graphite Medical EUDAMED

Active European Union

Ref H3 XL, H3 UBLA, H3 M, H3 XS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number36156H32F Basic UDI-DIDate9 Mar 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  • Withdrawn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
H3
Model / Reference
H3 XL, H3 UBLA, H3 M, H3 XS
Primary DI / UDI-DI
03615650000804, 03615650000262, 03615650000774, 03615650000798
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002504

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