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Stephens Instruments S3-1010

by Krishna Imports Inc

Ref S3-1010

Stephens Instruments S3-1010 is a razor blade breaker/holder (EU MDD Class I; FDA Class I; FDA product code HXK, Holder, Needle; Orthopedic) made by Krishna Imports Inc, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI B-00810799031518) and listed in FDA GUDID since 22 Sep 2020 (UDI-DI 00810799031518), 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-00810799031518 Basic UDI-DI 00810799031518UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810799031518 UDI-DI Date22 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810799031518 registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 00810799031518 listed 22 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810799031518
  2. Registered EUDAMED B-00810799031518

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  • Withdrawn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
Razor blade breaker/holder
Device name
Stephens Blade Breaker, Straight, Small Square Jaws
Model / Ref / Catalog
S3-1010
Primary DI / UDI-DI
00810799031518
Basic UDI-DI
B-00810799031518
FDA product code
HXK
EMDN code
L010103 Handles for scalpels, reusable
GMDN term
Razor blade breaker/holder
Device class
Class I
Regulation number
888.4540
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: Razor blade breaker/holder

Similar devices in this category

Other devices filed under HANDLES FOR SCALPELS, REUSABLE.

Other devices from Krishna Imports Inc

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Properties

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