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Breas

by Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. 13 variants

Ref 005519

Active European Union

CE MDR 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-+M4850055191F Basic UDI-DI Date23 May 2022RegisteredStatusActive
European UnionCE/MDD NumberB-+M4850055191F Basic UDI-DI Date23 May 2022RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
15mm Dual Limb Breathing Circuit
DOUBLE LINE/DOUBLE LUMEN BREATHING CIRCUIT (Non-Sterile)
Model / Reference
005519
Primary DI / UDI-DI
+M4850055191F, 07321820055197
Basic UDI-DI
B-+M4850055191F, ++M485BCNS0010ZU
Direct Marketing DI
07321820055197
EMDN Code
R02010101 Breathing circuits, w/o water trap
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000014943

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

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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