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Tyvek Steri̇li̇zasyon Rulosu 45CMX70MT

by Sudemed Tibbi̇ Ürünler Emlak İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Ref TY4570

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 Number868020228SUDEMEDTM Basic UDI-DI 08680202286079UDI-DIDate16 Mar 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  • Withdrawn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
Tyvek Steri̇li̇zasyon Rulosu 10CMX70M
Model / Reference
TY4570
Primary DI / UDI-DI
08680202286079
Basic UDI-DI
868020228SUDEMEDTM
Direct Marketing DI
08680202286079
EMDN Code
S01020201 Flat sterilisation reels, tyvek/plastic film
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000035283

Other devices from Sudemed Tibbi̇ Ürünler Emlak İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Sudemed Tibbi̇ Ürünler Emlak İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

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