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Conmed UHD5500XL

by Conmed Corporation

Ref UHD5500XL

Conmed UHD5500XL is a device classified as Class IIa in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 3 Apr 2026 (Basic UDI-DI B-10845854043738), cleared under FDA 510(k) K941541 on 16 May 1994 and listed in FDA GUDID since 7 Oct 2016 (UDI-DI 10845854043738), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K941541

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10845854043738 Basic UDI-DI 10845854043738UDI-DIDate3 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854043738 UDI-DI Date7 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK941541 Date16 May 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10845854043738 registered 3 Apr 2026 Active
  • FDA 510(k) K941541 decided 16 May 1994 Active
  • FDA GUDID UDI-DI 10845854043738 listed 7 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K941541
  2. Listed FDA GUDID 10845854043738
  3. Registered EUDAMED B-10845854043738

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Conmed
Generic name
Rigid optical laparoscope
Device name
Orthopedic, Non-active, Laparoscope
Model / Ref / Catalog
UHD5500XL
Primary DI / UDI-DI
10845854043738
Basic UDI-DI
B-10845854043738
510(k) Number
FDA product code
GCJ
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.5 Millimeter

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: Rigid optical laparoscope

Cleared under the same submission (K941541)

and 8 more cleared under K941541

Similar devices in this category

Other devices filed under LAPAROSCOPES.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)