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ProneView D28580CE

by Dupaco, Inc.

Part of a family of 13 devices: see the family page

Ref D28580CE

ProneView D28580CE is a Class I device made by Dupaco, Inc., registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 0850017419PRONEVIEWNW) and listed in FDA GUDID since 30 Oct 2020 (UDI-DI 10850017419244), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850017419PRONEVIEWNW Basic UDI-DI 10850017419244UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850017419244 UDI-DI Date30 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850017419PRONEVIEWNW registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 10850017419244 listed 30 Oct 2020 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 10850017419244
  2. Registered EUDAMED 0850017419PRONEVIEWNW

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  • Withdrawn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
ProneView® Protective Helmet System EUDAMED
ProneView GUDID
Generic name
Surgical helmet system
Device name
ProneView Protective Helmet System
Model / Ref / Catalog
D28580CE
Primary DI / UDI-DI
10850017419244
Basic UDI-DI
0850017419PRONEVIEWNW
Direct marketing DI
10850017419244
FDA product code
CCX
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Surgical helmet system
Device class
Class I
Regulation number
868.6820
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical helmet system

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Dupaco, Inc.

See all devices from Dupaco, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)