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Sub-Annular Implant

by HighLife France EUDAMED

Ref 631105-28S EMDN P07030499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850035587631105-28SFD Basic UDI-DIDate7 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2292597CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    31 Jul 2026
    Expires
    1 Jan 2031
    Reason
    Add device or group
  • 2292597TD01 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    31 Jul 2026
    Expires
    1 Jan 2031
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
631105-28S
Primary DI / UDI-DI
00850035587034
Basic UDI-DI
0850035587631105-28SFD
EMDN Code
P07030499 Heart valve rings - other
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
FR-MF-000015887

Other devices from HighLife

See all devices from HighLife →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 00850035587034|0850035587631105-28SFD 61 fields · synced 25 Oct 2026