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Sugi 30617

by QuestAlpha GmbH & Co. KG

Ref 30617

Sugi 30617 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 22 Mar 2018 (UDI-DI 04260306710331), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426030671NONST8D Basic UDI-DI 04260306710331UDI-DIDate21 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04260306710331 UDI-DI Date22 Mar 2018ListedStatusListed 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 04260306710331 listed 22 Mar 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260306710331
  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  • Withdrawn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 Eyespear, Cellulose, round blue handle, 17 x 8 mm, non-sterile, 500 x 10 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
30617
Primary DI / UDI-DI
04260306710331
Basic UDI-DI
426030671NONST8D
Direct marketing DI
04260306710331
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

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 04260306710331: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 04260306710331: EUDAMED states Yes, FDA GUDID states No.

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

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)