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Primado2 P200-1ARA-W

by Nakanishi Inc.

Ref P200-1ARA-WModel MDA0000110

Primado2 P200-1ARA-W is a Class I device made by Nakanishi Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 45602249800001106R), cleared under FDA 510(k) K132264 on 17 Dec 2013 and listed in FDA GUDID since 22 Jan 2025 (UDI-DI 04560264528994), 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 Number45602249800001106R Basic UDI-DI 04560264528994UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264528994 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 45602249800001106R registered 28 Oct 2026 Active
  • FDA 510(k) K132264 decided 17 Dec 2013 Active
  • FDA GUDID UDI-DI 04560264528994 listed 22 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132264
  2. Listed FDA GUDID 04560264528994
  3. Registered EUDAMED 45602249800001106R

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  • Withdrawn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
Burring power tool attachment
Model / reference
P200-1ARA-W, MDA0000110
Primary DI / UDI-DI
04560264528994
Basic UDI-DI
45602249800001106R
FDA product code
HWE
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Burring power tool attachment
Device class
Class I
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Burring power tool attachment

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

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