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ROHO® DRY FLOATATION® Mattress Overlay System

by ROHO, Inc. 6 variants

Ref MATTSECT1710

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 Number613732NMOWL Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
Neoprene Mattress Overlays
Model / Reference
MATTSECT1710
Primary DI / UDI-DI
00613732066680
Basic UDI-DI
613732NMOWL
EMDN Code
V080702 Non active anti-decubitus medical mattresses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018363
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Roho, Inc.

See all devices from Roho, Inc. →

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