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Eyetec 40-831

by Network Medical Products, Ltd.

Ref 40-831Model LASIK Eye Drain

Eyetec 40-831 is a device classified as Class I in the EU and Class II in the US made by Network Medical Products, Ltd., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-05060165018833), cleared under FDA 510(k) K130117 on 29 Oct 2013 and listed in FDA GUDID since 6 Aug 2019 (UDI-DI 05060165018833), 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) K130117

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-05060165018833 Basic UDI-DI 05060165018833UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060165018833 UDI-DI Date6 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130117 Date29 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05060165018833 registered 5 Nov 2026 Active
  • FDA 510(k) K130117 decided 29 Oct 2013 Active
  • FDA GUDID UDI-DI 05060165018833 listed 6 Aug 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130117
  2. Listed FDA GUDID 05060165018833
  3. Registered EUDAMED B-05060165018833

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  • Withdrawn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
Eyetec© EUDAMED
Eyetec GUDID
Generic name
Ophthalmic sponge
Device name
PVA and Cellulose Ophthalmic (sterile, patient contacting)
Model / reference
40-831, LASIK Eye Drain
Primary DI / UDI-DI
05060165018833 EUDAMED
05060165012497 GUDID
Basic UDI-DI
B-05060165018833
510(k) Number
FDA product code
HOZ
EMDN code
Q0299 Ophthalmic devices - 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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05060165018833
GUDID
05060165012497
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060165018833; FDA GUDID lists 05060165012497), so their flags are not compared. 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 (K130117)

and 8 more cleared under K130117

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Network Medical Products, Ltd.

See all devices from Network Medical Products, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)