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Primado2 FC-73

by Nakanishi Inc.

Ref FC-73Model MDA0000001

Primado2 FC-73 is a device classified as Class I in the EU and Class II in the US made by Nakanishi Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 45602249800000016K), cleared under FDA 510(k) K132264 on 17 Dec 2013 and listed in FDA GUDID since 22 Jan 2025 (UDI-DI 04560264529243), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132264

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number45602249800000016K Basic UDI-DI 04560264529243UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264529243 UDI-DI Date22 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132264 Date17 Dec 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45602249800000016K registered 3 Nov 2026 Active
  • FDA 510(k) K132264 decided 17 Dec 2013 Active
  • FDA GUDID UDI-DI 04560264529243 listed 22 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132264
  2. Listed FDA GUDID 04560264529243
  3. Registered EUDAMED 45602249800000016K

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  • Withdrawn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
Primado2
Generic name
Foot-switch, electrical
Model / reference
FC-73, MDA0000001
Primary DI / UDI-DI
04560264529243
Basic UDI-DI
45602249800000016K
Direct marketing DI
04589551365203
FDA product code
HBC
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4360
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
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.

Related devices

Category: Foot-switch, electrical

Cleared under the same submission (K132264)

and 8 more cleared under K132264

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - 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)