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Primado2 P200-EZ-WPD

by Nakanishi Inc.

Ref P200-EZ-WPDModel MDA0000119

Primado2 P200-EZ-WPD is a Class I device made by Nakanishi Inc., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 45602249800001197B), cleared under FDA 510(k) K163483 on 15 Aug 2017 and listed in FDA GUDID since 5 Jun 2020 (UDI-DI 04560264534162), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163483

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number45602249800001197B Basic UDI-DI 04560264534162UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264534162 UDI-DI Date5 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163483 Date15 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45602249800001197B registered 1 Sep 2026 Active
  • FDA 510(k) K163483 decided 15 Aug 2017 Active
  • FDA GUDID UDI-DI 04560264534162 listed 5 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163483
  2. Listed FDA GUDID 04560264534162
  3. Registered EUDAMED 45602249800001197B

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  • Withdrawn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
Surgical instrument maintenance lubricant
Model / reference
P200-EZ-WPD, MDA0000119
Primary DI / UDI-DI
04560264534162 EUDAMED
04589551356447 GUDID
Basic UDI-DI
45602249800001197B
510(k) Number
FDA product code
EFB
EMDN code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN term
Surgical instrument maintenance lubricant
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
Primary DI / UDI-DIEUDAMED
04560264534162
GUDID
04589551356447

The registries describe this device under different primary UDI-DIs (EUDAMED lists 04560264534162; FDA GUDID lists 04589551356447), so their flags are not compared.

Related devices

Category: Surgical instrument maintenance lubricant

Cleared under the same submission (K163483)

and 6 more cleared under K163483

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)