Skip to content

Varilite Evolution Wave

by Cascade Designs, Inc. 132 variants

Ref 71002116161

Varilite Evolution Wave (71002116161) is a Class I device made by Cascade Designs, Inc., registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 04081800010FG) and listed in FDA GUDID since 17 Aug 2023 (UDI-DI 00040818915769), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number04081800010FG Basic UDI-DI 00040818915769UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00040818915769 UDI-DI Date17 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 04081800010FG registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 00040818915769 listed 17 Aug 2023 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00040818915769
  2. Registered EUDAMED 04081800010FG

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  • Withdrawn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
Evolution Wave LPB 16X16 MSH EUDAMED
Varilite GUDID
Generic name
Air-filled chair cushion
Device name
VARILITE Evolution and Solo Seating Systems
Model / Ref / Catalog
71002116161, Evolution Wave
Primary DI / UDI-DI
00040818915769
Basic UDI-DI
04081800010FG
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
71002116161
GUDID
Evolution Wave

Related devices

Category: Air-filled chair cushion

Similar devices in this category

Other devices filed under HEALTHCARE ACTIVITIES SUPPORTIVE EQUIPMENT AND AIDS.

Other devices from Cascade Designs, Inc.

See all devices from Cascade Designs, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)