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Opti-Gard D28300CE

by Dupaco, Inc.

Ref D28300CE

Opti-Gard D28300CE is a Class I device made by Dupaco, Inc., registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 0850017419OPTIGARDWE) and listed in FDA GUDID since 30 Oct 2020 (UDI-DI 00850017419049), 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 Number0850017419OPTIGARDWE Basic UDI-DI 00850017419049UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850017419049 UDI-DI Date30 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850017419OPTIGARDWE registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 00850017419049 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 00850017419049
  2. Registered EUDAMED 0850017419OPTIGARDWE

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  • Withdrawn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
Opti-Gard® Patient Eye Protectors EUDAMED
Opti-Gard GUDID
Generic name
Eye splash shield, single-use
Device name
Opti-Gard Patient Eye Protectors
Model / Ref / Catalog
D28300CE
Primary DI / UDI-DI
00850017419049 EUDAMED
10850017419046 GUDID
Basic UDI-DI
0850017419OPTIGARDWE
FDA product code
HOY, IWS
EMDN code
Q021199 Ophthalmic surgery instruments, single-use - other
GMDN term
Eye splash shield, single-use
Device class
Class I
Regulation number
886.4750, 892.6500
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
Primary DI / UDI-DIEUDAMED
00850017419049
GUDID
10850017419046

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00850017419049; FDA GUDID lists 10850017419046), so their flags are not compared.

Related devices

Category: Eye splash shield, single-use

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - 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)