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Repros

by Ceramisys Limited EUDAMED

Active European Union

Ref 500-00-15

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506017162HATCPZ9 Basic UDI-DIDate14 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 780338 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    21 May 2026
    Expires
    20 May 2031

Specification

EUDAMED

Device Name
Hatcp
Model / Reference
500-00-15
Primary DI / UDI-DI
05060171627388
Basic UDI-DI
506017162HATCPZ9
EMDN Code
P900401 Bone and tendon replacement devices
Device Class
Class III
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000008083
Authorised representative
Medical Device Management Ltd IE-AR-000002496

Other devices from Ceramisys Ltd

See all devices from Ceramisys Ltd →

Properties

  • 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