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Stephens Instruments S4-1458

by Krishna Imports Inc

Ref S4-1458

Stephens Instruments S4-1458 is a Class I device made by Krishna Imports Inc, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI B-00810061911876) and listed in FDA GUDID since 23 Feb 2024 (UDI-DI 00810061911876), 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-00810061911876 Basic UDI-DI 00810061911876UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810061911876 UDI-DI Date23 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810061911876 registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 00810061911876 listed 23 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810061911876
  2. Registered EUDAMED B-00810061911876

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  • Withdrawn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 calliper
Model / Ref / Catalog
S4-1458
Primary DI / UDI-DI
00810061911876
Basic UDI-DI
B-00810061911876
FDA product code
HOE
EMDN code
L179001 Ophthalmology surgical gauges, reusable
GMDN term
Ophthalmic calliper
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 calliper

Similar devices in this category

Other devices filed under OPHTHALMOLOGY SURGICAL GAUGES, REUSABLE.

Other devices from Krishna Imports Inc

See all devices from Krishna Imports Inc →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)