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Sugi 30761

by QuestAlpha GmbH & Co. KG

Ref 30761

Sugi 30761 is a device classified as Class I in the EU and Class II in the US made by QuestAlpha GmbH & Co. KG, registered in EUDAMED on 21 May 2025 (Basic UDI-DI 426030671NONST8D) and listed in FDA GUDID since 8 Jul 2024 (UDI-DI 04260306710164), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426030671NONST8D Basic UDI-DI 04260306710164UDI-DIDate21 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04260306710164 UDI-DI Date8 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426030671NONST8D registered 21 May 2025 Active
  • FDA GUDID UDI-DI 04260306710164 listed 8 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260306710164
  2. Registered EUDAMED 426030671NONST8D

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  • Withdrawn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
Sugi Sponge Points, triangular, 17 x 8 mm, non-sterile, 500 pcs. EUDAMED
Sugi GUDID
Generic name
Ophthalmic sponge
Device name
Sugi Eyespear (pointed tip), non-sterile, 17 x 7mm, 20 x 10 pcs.
Model / Ref / Catalog
30761
Description
Sugi Sponge Points, triangular, non-sterile 17 x 8 mm, 500 pcs.
Primary DI / UDI-DI
04260306710164
Basic UDI-DI
426030671NONST8D
Direct marketing DI
04260306710164
FDA product code
HOZ
EMDN code
M040299 Non-adhesive absorbent dressings - other
GMDN term
Ophthalmic sponge
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.4790
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic sponge

Similar devices in this category

Other devices filed under NON-ADHESIVE ABSORBENT DRESSINGS - OTHER.

Other devices from QuestAlpha GmbH & Co. KG

See all devices from QuestAlpha GmbH & Co. KG →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
Other properties (21, all answered No)