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Kijimea® Reizdarm

by Synformulas GmbH Germany EUDAMED

EMDN G0401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-KR8K Basic UDI-DIDate20 Jul 2023RegisteredStatusActive
European UnionCE/MDR NumberB-KR8K Basic UDI-DIDate20 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Kijimea® Reizdarm
Kijimea® Reizdarm Pro
Primary DI / UDI-DI
D-KR8K, 111599965385, 111599967641, 111599968207, 111890682412, 112031272403
Basic UDI-DI
B-KR8K, PP07498KPRO16
Unit of Use DI
111910240142
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000016381

From the manufacturer

Manufacturer's product page: Gebrauchsanweisung herunterladen

Other devices from Synformulas GmbH

See all devices from Synformulas GmbH →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (6)

  • EUDAMED a07664e7-0f61-4666-a2c0-c5565048172e 61 fields · synced 22 Oct 2026
  • EUDAMED 111599965385|PP07498KPRO16 61 fields · synced 16 May 2026
  • EUDAMED 111599967641|PP07498KPRO16 61 fields · synced 17 May 2026
  • EUDAMED 111599968207|PP07498KPRO16 61 fields · synced 17 May 2026
  • EUDAMED 111890682412|PP07498KPRO16 61 fields · synced 18 May 2026
  • EUDAMED 112031272403|PP07498KPRO16 61 fields · synced 18 May 2026