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TYVEK STERILIZATION POUCHE 20cm*25cm

by Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.ltd. Şti̇

Ref FTM-00-100Model TYVEK STERILIZATION POUCHE

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868116145TYSPQ5 Basic UDI-DI 08681161451003UDI-DIDate27 Sep 2024RegisteredStatusActive

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  • Withdrawn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 Sterilization Pouche
Model / Reference
TYVEK STERILIZATION POUCHE, FTM-00-100
Primary DI / UDI-DI
08681161451003
Basic UDI-DI
868116145TYSPQ5
Direct Marketing DI
08681161451003
EMDN Code
S01010201 Flat sterilisation pouches, tyvek/plastic film
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000042201

Other devices from Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.ltd. Şti̇

See all devices from Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.ltd. Şti̇ →

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