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Biçakcilar

by Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 313 variants

Ref 107 0001 1Model B-FLOW II FLOW REGULATOR-W/INFUSION SET

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08695476008968 Basic UDI-DI 08695476008968UDI-DIDate19 Aug 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
B-FLOW II FLOW REGULATOR-W/INFUSION SET, 107 0001 1
Primary DI / UDI-DI
08695476008968
Basic UDI-DI
B-08695476008968
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022603

Other devices from Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Sterile
  • Administering Medicine
  • Measuring Function

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No