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28163PEL

by Karl Storz SE & CO. KG

Ref 28163PEL

28163PEL 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 15 Oct 2026 (Basic UDI-DI 4048551000901TT) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04048551101674), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551000901TT Basic UDI-DI 04048551101674UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551101674 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000901TT registered 15 Oct 2026 Active
  • FDA GUDID UDI-DI 04048551101674 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551101674
  2. Registered EUDAMED 4048551000901TT

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  • Withdrawn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
General-purpose endoscopic needle, reusable
Device name
Access instruments, metal
Model / Ref / Catalog
28163PEL
Primary DI / UDI-DI
04048551101674
Basic UDI-DI
4048551000901TT
FDA product code
HRX
EMDN code
L0925 Orthopaedic surgery dilators, reusable
GMDN term
General-purpose endoscopic needle, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.1100
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: General-purpose endoscopic needle, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY DILATORS, REUSABLE.

Other devices from Karl Storz SE & CO. KG

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

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)