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498820

by Karl Storz SE & CO. KG

Ref 498820

498820 is a device classified as Class IIa in the EU and Class I in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001305TC) and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 04048551169865), 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 Number4048551001305TC Basic UDI-DI 04048551169865UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551169865 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001305TC registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551169865 listed 4 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551169865
  2. Registered EUDAMED 4048551001305TC

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  • Withdrawn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
Tendon/ligament graft preparation station
Device name
Tissue preparation instruments, ENT, metal
Model / reference
498820
Primary DI / UDI-DI
04048551169865
Basic UDI-DI
4048551001305TC
FDA product code
LRC
EMDN code
Q0399 ENT devices - other
GMDN term
Tendon/ligament graft preparation station
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Tendon/ligament graft preparation station

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

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
  • Lot / batch number
Other properties (21, all answered No)