Skip to content

Giraffe Blue Spot PT Lite

by Datex-Ohmeda Inc. 51 variants

Ref M1238503

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 Number8406821BUG00394HW Basic UDI-DI 00195278838254UDI-DIDate27 May 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  • Withdrawn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
M1238503
Primary DI / UDI-DI
00195278838254
Basic UDI-DI
8406821BUG00394HW
Direct Marketing DI
00195278838254
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIa
EU market of registration
Norway

Manufacturer details

EUDAMED SRN
US-MF-000002206
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

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