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ROHO Hybrid Elite Dual Compartment Cushion 2RHE1720HD

by Roho, Inc.

Ref 2RHE1720HD

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number613732NFCV7 Basic UDI-DI 00613732116545UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613732116545 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ROHO® Hybrid Elite® Dual Compartment Cushion EUDAMED
ROHO Hybrid Elite Dual Compartment Cushion GUDID
Generic Name
Air-filled chair cushion
Device Name
Neoprene and Foam Cushion
Model / Reference
2RHE1720HD
Primary DI / UDI-DI
00613732116545
Basic UDI-DI
613732NFCV7
FDA Product Code
KIC
EMDN Code
V08030102 Non-active anti-decubitus medical cushions
GMDN Term
Air-filled chair cushion
Device Class
Class I
Regulation Number
890.3175
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Roho, Inc.

See all devices from Roho, Inc. →

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No