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Opbouw Saturatie Masimo RAD-8

by rdgKompagne

Ref OPB-SATU-RAD8

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0175008/OPB-SATU/NS Basic UDI-DI 08721593205062UDI-DIDate1 Jun 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  • Withdrawn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

Device Name
Opbouw Saturatie
Model / Reference
OPB-SATU-RAD8
Primary DI / UDI-DI
08721593205062
Basic UDI-DI
0175008/OPB-SATU/NS
Direct Marketing DI
08721593205062
EMDN Code
Y122499 Wheelchairs accessories - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000041828

Other devices from rdgKompagne

See all devices from rdgKompagne →

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