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Redsense Alarm unit with FOE, IFU, charger EU

by Redsense Medical AB

Ref RA-1-RA201-AModel Redsense Alarm unit with FOE, IFU, charger EU

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 Number7350078030021VY Basic UDI-DI 07350078030021UDI-DIDate9 Jan 2025RegisteredStatusActive

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  • Withdrawn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
Redsense Alarm unit with FOE, IFU, charger EU, RA-1-RA201-A
Primary DI / UDI-DI
07350078030021
Basic UDI-DI
7350078030021VY
Direct Marketing DI
07350078030021
EMDN Code
F9099 Dialysis devices - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
SE-MF-000005240

Other devices from Redsense Medical AB

See all devices from Redsense Medical AB →

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