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Mediflex

by Mediflex Medikal 118 variants

Ref MF 5011Model BPAP Ventilator Breathing Circuit with Sensor

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 linked in EUDAMED

A group certificate may exist

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 Number868127782TD-016ER Basic UDI-DI 08681277821028UDI-DIDate27 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ventilator Breathing Circuit
Model / Reference
BPAP Ventilator Breathing Circuit with Sensor, MF 5011
Primary DI / UDI-DI
08681277821028
Basic UDI-DI
868127782TD-016ER
Direct Marketing DI
08681277821028
EMDN Code
R02010401 Cpap circuits
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000036464

Other devices from Mediflex Medikal

See all devices from Mediflex Medikal →

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