Skip to content

Collection Kit 4

by Remi Health GmbH

Ref P-Box-A-Var4-5x1163

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 Number42624479002NN Basic UDI-DI 04262447940509UDI-DIDate31 Aug 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  • Withdrawn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
Urin - Probenahme, Aufbewahrungs und Einsende Kit
Model / Reference
P-Box-A-Var4-5x1163
Primary DI / UDI-DI
04262447940509
Basic UDI-DI
42624479002NN
EMDN Code
W05010202 Urine collection, tubes
Device Class
Class I
Medical Purpose
Diese Behandlungseinheit dient der Entnahme einer Urinprobe durch Laienanwender:innen in der häuslichen Umgebung, der primären Aufbewahrung, Erhaltung sowie dem Probenversand in ein Kooperationslabor.

Manufacturer details

EUDAMED SRN
DE-PR-000043145

Other devices from Remi Health GmbH

See all devices from Remi Health GmbH →

Properties

Other properties (1)

  • Sterile: No