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Torque Calibrator

by Nakanishi Inc.

Ref Z1056001Model MDA0000062

Torque Calibrator is a Class I device made by Nakanishi Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 456022498000006277), cleared under FDA 510(k) K110278 on 15 Feb 2012 and listed in FDA GUDID since 20 Nov 2020 (UDI-DI 04560264522336), 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) K110278

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number456022498000006277 Basic UDI-DI 04560264522336UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264522336 UDI-DI Date20 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110278 Date15 Feb 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 456022498000006277 registered 2 Oct 2026 Active
  • FDA 510(k) K110278 decided 15 Feb 2012 Active
  • FDA GUDID UDI-DI 04560264522336 listed 20 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110278
  2. Listed FDA GUDID 04560264522336
  3. Registered EUDAMED 456022498000006277

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  • Withdrawn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

Generic name
Power tool torque control unit
Model / reference
MDA0000062 EUDAMED
Z1056001 EUDAMED
Torque Calibrator GUDID
Primary DI / UDI-DI
04560264522336
Basic UDI-DI
456022498000006277
510(k) Number
FDA product code
EKX
EMDN code
Z12139080 Various orthopaedic and traumatology instruments - hardware accessories
GMDN term
Power tool torque control unit
Device class
Class I
Regulation number
872.4200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MDA0000062
Z1056001
GUDID
Torque Calibrator

Related devices

Category: Power tool torque control unit

Cleared under the same submission (K110278)

Similar devices

Also classified as Power tool torque control unit.

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)