Skip to content

ProneView D28507CE

by Dupaco, Inc.

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

Ref D28507CE

ProneView D28507CE 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 00850017419100), 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 Number0850017419PRONEVIEWNW Basic UDI-DI 00850017419100UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850017419100 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 00850017419100 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 00850017419100
  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  • Withdrawn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
Freestanding patient positioner, single-use
Device name
ProneView Protective Helmet System
Model / Ref / Catalog
D28507CE
Primary DI / UDI-DI
00850017419100 EUDAMED
10850017419107 GUDID
Basic UDI-DI
0850017419PRONEVIEWNW
FDA product code
CCX
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Freestanding patient positioner, single-use
Device class
Class I
Regulation number
868.6820
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00850017419100
GUDID
10850017419107

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00850017419100; FDA GUDID lists 10850017419107), so their flags are not compared.

Related devices

Category: Freestanding patient positioner, single-use

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)