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Stephens Instruments SC-1316

by Krishna Imports Inc

Ref SC-1316

Stephens Instruments SC-1316 is a Class I device made by Krishna Imports Inc, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI B-00810799038364) and listed in FDA GUDID since 22 Sep 2020 (UDI-DI 00810799038364), 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-00810799038364 Basic UDI-DI 00810799038364UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810799038364 UDI-DI Date22 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810799038364 registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 00810799038364 listed 22 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810799038364
  2. Registered EUDAMED B-00810799038364

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  • Withdrawn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 irrigation/infusion/aspiration cannula, non-illuminating, reusable
Model / Ref / Catalog
SC-1316
Primary DI / UDI-DI
00810799038364
Basic UDI-DI
B-00810799038364
FDA product code
HMX
EMDN code
L1713 Ocular irrigation or suction cannulas, reusable
GMDN term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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 irrigation/infusion/aspiration cannula, non-illuminating, reusable

Similar devices in this category

Other devices filed under OPHTHALMOLOGY INSTRUMENTS, REUSABLE.

Other devices from Krishna Imports Inc

See all devices from Krishna Imports Inc →

Properties

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