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Flexicare

by Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. Türkiye EUDAMED

Ref 1000080259

EMDN R040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++M485FLTS0082CB Basic UDI-DIDate6 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Tracheostomy Filters (Sterile)
Model / Reference
1000080259
Primary DI / UDI-DI
08697645009370
Basic UDI-DI
++M485FLTS0082CB
Direct Marketing DI
08697645009370
EMDN Code
R040201 Tracheostomy humidifiers
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000014943

Other devices from Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş.

See all devices from Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 852bb2ef-e504-41b4-b36c-109977b2b852 61 fields · synced 23 Oct 2026