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Instrument Wipe 9101

by Hurricane Medical

Ref 9101

Instrument Wipe 9101 is a device classified as Class IIa in the EU and Class II in the US made by Hurricane Medical, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00813465012064), cleared under FDA 510(k) K990671 on 10 May 1999 and listed in FDA GUDID since 16 Feb 2017 (UDI-DI 00813465012064), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K990671

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813465012064 Basic UDI-DI 00813465012064UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813465012064 UDI-DI Date16 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK990671 Date10 May 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00813465012064 registered 30 Oct 2026 Active
  • FDA 510(k) K990671 decided 10 May 1999 Active
  • FDA GUDID UDI-DI 00813465012064 listed 16 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K990671
  2. Listed FDA GUDID 00813465012064
  3. Registered EUDAMED B-00813465012064

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
9101 Instrument Wipe EUDAMED
Instrument Wipe GUDID
Generic name
Ophthalmic sponge
Model / Ref / Catalog
9101
Primary DI / UDI-DI
00813465012064
Basic UDI-DI
B-00813465012064
510(k) Number
FDA product code
HOZ
EMDN code
M040302, V0799
GMDN term
Ophthalmic sponge
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4790
EU registration type
Legacy device (under a directive)
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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

Cleared under the same submission (K990671)

and 8 more cleared under K990671

Similar devices in this category

Other devices filed under OPHTHALMIC DRESSINGS.

Other devices from Hurricane Medical

See all devices from Hurricane Medical →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)