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Confort

by Konfort Ozel Saglik Hizmetleri Tibbi Malz San Ve Tic Ltd Sti 26 variants

Ref NDSSCD1000Model ONE PIECE

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868001400OSTT001LD Basic UDI-DI 08680014007800UDI-DIDate4 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
One Piece Colostomy & Ileostomy Bag Drainable Opaque 70MM
Model / Reference
ONE PIECE, NDSSCD1000
Primary DI / UDI-DI
08680014007800
Basic UDI-DI
868001400OSTT001LD
Direct Marketing DI
08680014007800
EMDN Code
A1001010101, A1001010102, A1001020101, A1001020102, A100199
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000014934

Other devices from Konfort Ozel Saglik Hizmetleri Tibbi Malz San Ve Tic Ltd Sti

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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