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Ostomy bag

by Shenzhen KRD Electronics Co., Ltd EUDAMED

Active European Union

Ref MDRModel K101、K102、K103、K104、K105、K106、K107、K108、K109、K110、K111、K112

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697930992KRDNo13Z Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Ostomy bag
Model / Reference
K101、K102、K103、K104、K105、K106、K107、K108、K109、K110、K111、K112, MDR
Primary DI / UDI-DI
06979309920002
Basic UDI-DI
697930992KRDNo13Z
EMDN Code
A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000050649
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Properties

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