Skip to content

S-Pilot UP004

by Karl Storz SE & CO. KG

Ref UP004

S-Pilot UP004 is a device classified as Class I in the EU and Class II in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551000362TH) and listed in FDA GUDID since 19 May 2017 (UDI-DI 04048551370414), 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 Number4048551000362TH Basic UDI-DI 04048551370414UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551370414 UDI-DI Date19 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000362TH registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551370414 listed 19 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551370414
  2. Registered EUDAMED 4048551000362TH

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  • Withdrawn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
S-Pilot
Generic name
Electrical-only medical device connection cable, reusable
Device name
Connecting cables
Model / reference
UP004
Primary DI / UDI-DI
04048551370414
Basic UDI-DI
4048551000362TH
FDA product code
GCX
EMDN code
Z12019004 Surgical smoke evacuation systems
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6740
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
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under SURGICAL SMOKE EVACUATION SYSTEMS.

Other devices from Karl Storz SE & CO. KG

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

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)