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Sterile disposable guide

by Koelis

Ref KDNG00Model Sterile disposable guide

Sterile disposable guide (KDNG00) is a device classified as Class I in the EU and Class II in the US made by Koelis, registered in EUDAMED on 2 Feb 2026 (Basic UDI-DI 3665134GuidesUU_01MR), cleared under FDA 510(k) K180970 on 10 Jul 2018 and listed in FDA GUDID since 20 Jul 2018 (UDI-DI 03665134000004), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180970↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3665134GuidesUU_01MR Basic UDI-DI 03665134000004UDI-DIDate2 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03665134000004 UDI-DI Date20 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK180970 Date10 Jul 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665134GuidesUU_01MR registered 2 Feb 2026 Active
  • FDA 510(k) K180970 decided 10 Jul 2018 Active
  • FDA GUDID UDI-DI 03665134000004 listed 20 Jul 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180970
  2. Listed FDA GUDID 03665134000004
  3. Registered EUDAMED 3665134GuidesUU_01MR

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Sterile disposable guide EUDAMED
Disposable guide for 3D endocavity end-fire GUDID
Generic name
Needle guide, single-use
Model / reference
Sterile disposable guide, KDNG00
Primary DI / UDI-DI
03665134000004 EUDAMED
03665134000011 GUDID
Basic UDI-DI
3665134GuidesUU_01MR
510(k) Number
FDA product code
ITX
EMDN code
Z11040185 Ultrasound scanners - consumables
GMDN term
Needle guide, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03665134000004
GUDID
03665134000011
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 03665134000004; FDA GUDID lists 03665134000011), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
FR-MF-000000830

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - CONSUMABLES.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)