Skip to content

Configured client-specific CozyZone Sleep System

by Blackstone Innovations Limited EUDAMED

Active European Union

Ref Configured client-specific CozyZone Sleep SystemModel CozyZone

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number507000CozyZoneRC Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
CozyZone
Model / Reference
CozyZone, Configured client-specific CozyZone Sleep System
Primary DI / UDI-DI
05070003585854
Basic UDI-DI
507000CozyZoneRC
EMDN Code
V080302 Patient positioning medical cushions
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000058496
Authorised representative
Euverify Ltd IE-AR-000048685

Other devices from Blackstone Innovations Limited

See all devices from Blackstone Innovations Limited →

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