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DrillCut-X 28200DX

by Karl Storz SE & CO. KG

Ref 28200DX

DrillCut-X 28200DX is a device classified as Class IIa 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 4048551000980UH) and listed in FDA GUDID since 17 Aug 2018 (UDI-DI 04048551373675), 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 Number4048551000980UH Basic UDI-DI 04048551373675UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551373675 UDI-DI Date17 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000980UH registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551373675 listed 17 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551373675
  2. Registered EUDAMED 4048551000980UH

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  • Withdrawn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
DrillCut-X
Generic name
Tissue morcellation system
Device name
Shaver handpieces
Model / reference
28200DX
Primary DI / UDI-DI
04048551373675
Basic UDI-DI
4048551000980UH
FDA product code
HRX
EMDN code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN term
Tissue morcellation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.1100
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 II

Device class is stated on each registry's own scale: Class IIa 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: Tissue morcellation system

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)