Skip to content

Dantec Clavis

by Natus Manufacturing Limited

Ref 9015A0012

Dantec Clavis (9015A0012) is a nerve-locating system (EU MDR Class IIa; FDA Class II) made by Natus Manufacturing Limited, registered in EUDAMED on 10 Apr 2026 (Basic UDI-DI 038283NA00008E3), cleared under FDA 510(k) K062478 on 8 Feb 2007 and listed in FDA GUDID since 12 Mar 2019 (UDI-DI 00382830049702), 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) K062478

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038283NA00008E3 Basic UDI-DI 00382830049702UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830049702 UDI-DI Date12 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK062478 Date8 Feb 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038283NA00008E3 registered 10 Apr 2026 Active
  • FDA 510(k) K062478 decided 8 Feb 2007 Active
  • FDA GUDID UDI-DI 00382830049702 listed 12 Mar 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062478
  2. Listed FDA GUDID 00382830049702
  3. Registered EUDAMED 038283NA00008E3

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  • Withdrawn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
Dantec Clavis EUDAMED
Clavis GUDID
Generic name
Nerve-locating system
Device name
Dante Clavis
Model / Ref / Catalog
9015A0012
Primary DI / UDI-DI
00382830049702
Basic UDI-DI
038283NA00008E3
Direct marketing DI
00382830049702
510(k) Number
FDA product code
GWL, BXN
EMDN code
Z120622, Z12100401
GMDN term
Nerve-locating system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1835, 868.2775
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
IE-MF-000000799

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHS.

Other devices from Natus Manufacturing Limited

See all devices from Natus Manufacturing Limited →

Properties

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