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Nail 14g

by Koelis

Ref NAIL.14Model Nail

Nail 14g (NAIL.14) is a device classified as Class I in the EU and Class II in the US made by Koelis, registered in EUDAMED on 25 Oct 2022 (Basic UDI-DI 3665134Nail_01NJ), cleared under FDA 510(k) K171040 on 31 Jul 2017 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 03665134000165), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171040

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03665134000165 UDI-DI Date4 Apr 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3665134Nail_01NJ Basic UDI-DI 03665134000165UDI-DIDate25 Oct 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171040 Date31 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665134Nail_01NJ registered 25 Oct 2022 Active
  • FDA 510(k) K171040 decided 31 Jul 2017 Active
  • FDA GUDID UDI-DI 03665134000165 listed 4 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171040
  2. Registered EUDAMED 3665134Nail_01NJ
  3. Listed FDA GUDID 03665134000165

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Nail 14g EUDAMED
NAIL range GUDID
Generic name
Needle guide, reusable
Model / reference
Nail, NAIL.14
Primary DI / UDI-DI
03665134000165
Basic UDI-DI
3665134Nail_01NJ
510(k) Number
FDA product code
ITX
EMDN code
Z11049080 Various ultrasound instruments - hardware accessories
GMDN term
Needle guide, reusable
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
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
FR-MF-000000830

Similar devices in this category

Other devices filed under VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Koelis

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Properties

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