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Kora 100 Sr

by MicroPort CRM S.r.l. Italy EUDAMED

Ref TPM007C, TPM006C, TPM013CModel KORA 100 SR, KORA 100 DR, KORA 250 SR

EMDN J01010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-08031527012735 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/AIMDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Kora 100 Sr
Kora 100 Dr
Kora 250 Sr
Device Name
Implantable Pacemaker System with a conditional intended use in MRI environment - KORA
Model / Reference
KORA 100 SR, TPM007C, KORA 100 DR, TPM006C, KORA 250 SR, TPM013C
Primary DI / UDI-DI
08031527012735, 08031527012711, 08031527014340
Basic UDI-DI
B-08031527012735, B-08031527012711, B-08031527014340
EMDN Code
J01010102, J01010302
Device Class
Class AIMDD
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029013

Other devices from MicroPort CRM S.r.l.

See all devices from MicroPort CRM S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 3468727a-dc5c-4f19-875e-1a76f300e507 61 fields · synced 24 Oct 2026
  • EUDAMED 08031527012711|B-08031527012711 61 fields · synced 18 May 2026
  • EUDAMED 08031527014340|B-08031527014340 61 fields · synced 18 May 2026