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Stephens Instruments S8-1100

by Krishna Imports Inc

Ref S8-1100

Stephens Instruments S8-1100 is a Class I device made by Krishna Imports Inc, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI B-00810799037367) and listed in FDA GUDID since 22 Sep 2020 (UDI-DI 00810799037367), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810799037367 Basic UDI-DI 00810799037367UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810799037367 UDI-DI Date22 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810799037367 registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 00810799037367 listed 22 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810799037367
  2. Registered EUDAMED B-00810799037367

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Stephens Instruments
Generic name
Ophthalmic surgical probe, reusable
Device name
Williams Lacrimal Bulbous Probe, S.Silver, 1-2
Model / Ref / Catalog
S8-1100
Primary DI / UDI-DI
00810799037367
Basic UDI-DI
B-00810799037367
FDA product code
HNW
EMDN code
L1705 Ophthalmology probes, reusable
GMDN term
Ophthalmic surgical probe, reusable
Device class
Class I
Regulation number
886.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Ophthalmic surgical probe, reusable

Similar devices in this category

Other devices filed under OPHTHALMOLOGY PROBES, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
Other properties (22, all answered No)