Skip to content

Kabel SPO2

by SORIMEX Sp. z o.o. 14 variants

Ref PK-GDB9w-33/L-220, GS 10728, PK-GDB9w-205D/L-220, PK-GDB9w-43/L-220, PK-GDB9w-28/L-220, PK-GDB9w-08/L-220, PK-GDB9x-180/L-300, PK-GDB9w-43/L-300, PK-G41-40/L-220, PK-GDB9w-29m/L-220, PK-RDB9/GDB9a/L-400, PK-GDB9w-48/L-220, PK-GDB9m-48/L-220, GS 1033O

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, self-declared

Class I: no certifier involved

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/MDR Number5903002221055E Basic UDI-DI Date22 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
PK-GDB9w-33/L-220, GS 10728, PK-GDB9w-205D/L-220, PK-GDB9w-43/L-220, PK-GDB9w-28/L-220, PK-GDB9w-08/L-220, PK-GDB9x-180/L-300, PK-GDB9w-43/L-300, PK-G41-40/L-220, PK-GDB9w-29m/L-220, PK-RDB9/GDB9a/L-400, PK-GDB9w-48/L-220, PK-GDB9m-48/L-220, GS 1033O
Primary DI / UDI-DI
05903002213483, 05908212625873, 05903002211274, 05903002212240, 05903002213537, 05903002212479, 05903002215333, 05903002213346, 05903002215357, 05903002215326, 05903002206843, 05903002213513, 05903002215265, 05903002211304
Basic UDI-DI
5903002221055E
EMDN Code
Z1203020680 Vital signs telemetry instruments - hardware accessories
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000020958

Other devices from SORIMEX Sp. z o.o.

See all devices from SORIMEX Sp. z o.o. →

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