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Ostomy Pouch

by Changzhou Cippor Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref Two-Piece Colostomy Bag 4301Model Two-Piece Colostomy Bag 4301: Double-sided brown high-barrier film, single-sided white nonwoven fabric, round activated carbon, 57 fastener, clip closure (clip ratio 10:2) Two-Piece Base Plate 7301: etc

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697856336XPOPZD Basic UDI-DIDate2 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Ostomy Pouch
Model / Reference
Two-Piece Colostomy Bag 4301: Double-sided brown high-barrier film, single-sided white nonwoven fabric, round activated carbon, 57 fastener, clip closure (clip ratio 10:2) Two-Piece Base Plate 7301: etc, Two-Piece Colostomy Bag 4301
Primary DI / UDI-DI
06978563360265
Basic UDI-DI
697856336XPOPZD
EMDN Code
A108001 Rings / bezels / plates for peristomal skin
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047243
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changzhou Cippor Medical Equipment Co., Ltd.

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