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Corneal Light Shield 9203

by Hurricane Medical

Ref 9203

Corneal Light Shield 9203 is a device classified as Class I in the EU and Class II in the US made by Hurricane Medical, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00813465012095), cleared under FDA 510(k) K990671 on 10 May 1999 and listed in FDA GUDID since 26 Apr 2016 (UDI-DI 00813465012095), 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-00813465012095 Basic UDI-DI 00813465012095UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813465012095 UDI-DI Date26 Apr 2016ListedStatusListed 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-00813465012095 registered 29 Oct 2026 Active
  • FDA 510(k) K990671 decided 10 May 1999 Active
  • FDA GUDID UDI-DI 00813465012095 listed 26 Apr 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K990671
  2. Listed FDA GUDID 00813465012095
  3. Registered EUDAMED B-00813465012095

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  • Withdrawn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
9203 Corneal Light Shield 6mm EUDAMED
Corneal Light Shield GUDID
Generic name
Ophthalmic sponge
Device name
Corneal Light Shield 6mm
Model / Ref / Catalog
9203
Primary DI / UDI-DI
00813465012095
Basic UDI-DI
B-00813465012095
510(k) Number
FDA product code
HOZ
EMDN code
M040399 Ophthalmic dressings - other
GMDN term
Ophthalmic sponge
Device class
Class I 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
Size
Outer Diameter — 6 Millimeter

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

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)