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TYVEK STERILIZATION REEL 5cm*70mt

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

Ref FTM-00-031Model TYVEK STREILIZATION REEL

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 Number868116145TYSRQ9 Basic UDI-DI 08681161450310UDI-DIDate25 Jun 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  • Withdrawn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

Model / Reference
TYVEK STREILIZATION REEL, FTM-00-031
Primary DI / UDI-DI
08681161450310
Basic UDI-DI
868116145TYSRQ9
Direct Marketing DI
08681161450310
EMDN Code
S01020201 Flat sterilisation reels, tyvek/plastic film
Device Class
Class I
EU market of registration
Türkiye

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