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Awamed

by Awamed Tıbbi Ürünler Sağlık Medikal İnşaat Üretim İthalat İhracat Ltd. Şti 26 variants

Ref PNCI03Model OKSİJEN MASKESİ YENİDOĞAN - KANÜLLÜ

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682851770091 Basic UDI-DI 08682851770091UDI-DIDate17 Sep 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  • Withdrawn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

Device Name
Oksi̇jen Maskesi̇ Yeni̇doğan - Kanüllü
Model / Reference
OKSİJEN MASKESİ YENİDOĞAN - KANÜLLÜ, PNCI03
Primary DI / UDI-DI
08682851770091
Basic UDI-DI
B-08682851770091
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000035574

Other devices from Awamed Tıbbi Ürünler Sağlık Medikal İnşaat Üretim İthalat İhracat Ltd. Şti

See all devices from Awamed Tıbbi Ürünler Sağlık Medikal İnşaat Üretim İthalat İhracat Ltd. Şti →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No