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Demopaket BabyFlow S, Einweg

by Drägerwerk AG & Co. KGaA

Ref MP16104Model 12080636K18Z00

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0404867512080636K18Z000V2 Basic UDI-DI 04048675755784UDI-DIDate25 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
12080636K18Z00, MP16104
Primary DI / UDI-DI
04048675755784
Basic UDI-DI
0404867512080636K18Z000V2
EMDN Code
R03010299 Oxygen therapy masks and nasal cannulas - other
Device Class
Class IIa
Medical Purpose
The BabyFlow 2.0 system (nasal interface and accessories) is designed to provide non-invasive respiratory support to spontaneously breathing patients.

Manufacturer details

EUDAMED SRN
DE-PR-000042941

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Properties

Other properties (1)

  • Sterile: No