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Sugi 30670

by QuestAlpha GmbH & Co. KG

Ref 30670

Sugi 30670 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 6 Sep 2019 (UDI-DI 04260306710416), 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 Number426030671NONST8D Basic UDI-DI 04260306710416UDI-DIDate21 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04260306710416 UDI-DI Date6 Sep 2019ListedStatusListed 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 04260306710416 listed 6 Sep 2019 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 04260306710416
  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  • Withdrawn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 iSpear (pointed tip), round light blue handle, non-sterile, 500 x 6 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
30670
Primary DI / UDI-DI
04260306710416
Basic UDI-DI
426030671NONST8D
Direct marketing DI
04260306710416
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 · 2 fields differ

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

Related devices

Category: Ophthalmic sponge

Other devices from QuestAlpha GmbH & Co. KG

See all devices from QuestAlpha GmbH & Co. KG →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)