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Poly Standard12/Softline 305 PK3

by Breckle Matratzenwerk Weida EUDAMED

Active European Union

Ref Poly Standard12/Softline 305 PK3 088/220, Poly Standard12/Softline 305 PK3 090/200, Poly Standard12/Softline 305 PK3 118/200, Poly Standard12/Softline 305 PK3 088/190, Poly Standard12/Softline 305 PK3 088/200, Poly Standard12/Softline 305 PK3 078/200

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40194730024F Basic UDI-DIDate12 Apr 2023RegisteredStatusActive

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  • Withdrawn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
medical mattress
Model / Reference
Poly Standard12/Softline 305 PK3 088/220, Poly Standard12/Softline 305 PK3 090/200, Poly Standard12/Softline 305 PK3 118/200, Poly Standard12/Softline 305 PK3 088/190, Poly Standard12/Softline 305 PK3 088/200, Poly Standard12/Softline 305 PK3 078/200
Primary DI / UDI-DI
04019473349024, 04019473348928, 04019473365628, 04019473365826, 04019473348720, 04019473348829
Basic UDI-DI
40194730024F
Direct Marketing DI
04019473349024
04019473348928
04019473365628
04019473365826
04019473348720
04019473348829
EMDN Code
V080702 Non active anti-decubitus medical mattresses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010222

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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