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Serenity T Vaporizer GEHC SEV Piramal-Fill EN-US, UK, ZA, AU, IL

by Datex-Ohmeda Inc.

Ref TS50G01NN00Model Serenity S, Serenity T

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406821BUG004777P Basic UDI-DI 00198953131053UDI-DIDate19 Sep 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Serenity S, Serenity T
Model / Reference
Serenity S, Serenity T, TS50G01NN00
Primary DI / UDI-DI
00198953131053
Basic UDI-DI
08406821BUG004777P
EMDN Code
Z1203010180 Anaesthesia systems - hardware accessories
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000014656
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • CMR Substance
  • Administering Medicine

Other properties (11)

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