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C-Mac 8403XSP

by Karl Storz SE & CO. KG

Ref 8403XSP

C-Mac 8403XSP 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 21 Jul 2018 (UDI-DI 04048551409558), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551001494UA Basic UDI-DI 04048551409558UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551409558 UDI-DI Date21 Jul 2018ListedStatusListed 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 04048551409558 listed 21 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551409558
  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  • Withdrawn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

Trade name
C-Mac
Generic name
Flexible intubation laryngoscope, video, reusable
Device name
Imagers
Model / Ref / Catalog
8403XSP
Primary DI / UDI-DI
04048551409558
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04048551409558: EUDAMED states Yes, FDA GUDID states No.

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

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Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)