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Across Aqua

by Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş. 2 variants

Ref 635052

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680196391520 Basic UDI-DI 08680196391520UDI-DIDate3 Jun 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  • Withdrawn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
Across Aqua Steril İnhalasyon Suyu 500 ml
Model / Reference
635052
Primary DI / UDI-DI
08680196391520
Basic UDI-DI
B-08680196391520
EMDN Code
R060202 Oxygen administration humidification systems
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000021449

Other devices from Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş.

  • Across Gel

    Class D
  • Across Aqua

    Class IIa
  • Across Gel

    Class D
  • Across Gel

    Class D
  • Across Gel

    Class A
  • Across Gel

    Class D

See all devices from Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş. →

Properties

  • Sterile

Other properties (10)

  • 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