Skip to content

8403XSB

by Karl Storz SE & CO. KG

Ref 8403XSB

8403XSB is a Class I device made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001494UA) and listed in FDA GUDID since 28 Mar 2025 (UDI-DI 04048551401484), active as of 22 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number4048551001494UA Basic UDI-DI 04048551401484UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551401484 UDI-DI Date28 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001494UA registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551401484 listed 28 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551401484
  2. Registered EUDAMED 4048551001494UA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Flexible intubation laryngoscope, video, reusable
Device name
Imagers
Model / Ref / Catalog
8403XSB
Primary DI / UDI-DI
04048551401484
Basic UDI-DI
4048551001494UA
FDA product code
CCW
EMDN code
Z12029006 Fibroscopes for intubation
GMDN term
Flexible intubation laryngoscope, video, reusable
Device class
Class I
Regulation number
868.5540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Flexible intubation laryngoscope, video, reusable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY.

Other devices from Karl Storz SE & CO. KG

See all devices from Karl Storz SE & CO. KG →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)