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Argo Knotless

by Conmed Corporation 6 variants

Ref K4755DBP

Argo Knotless (K4755DBP) is a device classified as Class IIa in the EU and Class I in the US made by Conmed Corporation, registered in EUDAMED on 5 Apr 2026 (Basic UDI-DI 084585408666DY) and listed in FDA GUDID since 25 Sep 2021 (UDI-DI 20845854649845), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084585408666DY Basic UDI-DI 20845854649845UDI-DIDate5 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854649845 UDI-DI Date25 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084585408666DY registered 5 Apr 2026 Active
  • FDA GUDID UDI-DI 20845854649845 listed 25 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20845854649845
  2. Registered EUDAMED 084585408666DY

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  • Withdrawn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
Bone-coring punch, single-use
Device name
Disposable Surgical Instruments
Model / Ref / Catalog
K4755DBP
Primary DI / UDI-DI
20845854649845
Basic UDI-DI
084585408666DY
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Bone-coring punch, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 20845854649845: EUDAMED states No, FDA GUDID states Yes.

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.

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
Conmed Europe BV BE-AR-000035662

Related devices

Category: Joint prosthesis implantation kit, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)