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Orthopedic foam mattress Osaka Air

by Onsen Sp. z o.o. 8 variants

Ref 5905868656916, 5905123515477, 5905868656954, 5905123515453, 5905123515439, 5905868656992, 5905868656893, 5905123515422, 590586865698Model 200cm x 200cm + Purotex, 200cm x 200cm, 140cm x 200cm + Purotex, 160cm x 200cm, 120cm x 200cm, 100cm x 200cm + Purotex, 90cm x 200cm + Purotex, 100cm x 200cm, 160cm x 200cm + Purotex

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 Number5905868656A08EG Basic UDI-DI Date27 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  • Withdrawn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
200cm x 200cm + Purotex, 5905868656916, 200cm x 200cm, 5905123515477, 140cm x 200cm + Purotex, 5905868656954, 160cm x 200cm, 5905123515453, 120cm x 200cm, 5905123515439, 100cm x 200cm + Purotex, 5905868656992, 90cm x 200cm + Purotex, 5905868656893, 100cm x 200cm, 5905123515422, 160cm x 200cm + Purotex, 590586865698
Primary DI / UDI-DI
59058686569164, 59051235154774, 59058686569546, 59051235154538, 59051235154392, 59058686569928, 59058686568938, 59051235154224, 59058686569850
Basic UDI-DI
5905868656A08EG, 5905123515008XT, 5905868656A05EA, 5905123515006XP, 5905123515004XK, 5905868656A03E6, 5905868656A02E4, 5905123515003XH, 5905868656A06EC
EMDN Code
V080702 Non active anti-decubitus medical mattresses
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000037523

Other devices from Onsen Sp. z o.o.

See all devices from Onsen 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