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Primado2 P200-2AM

by Nakanishi Inc.

Ref P200-2AM

Primado2 P200-2AM is a device classified as Class IIa in the EU and Class II in the US made by Nakanishi Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-04560264530065), cleared under FDA 510(k) K132264 on 17 Dec 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04560264530065), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K132264

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/MDD EUDAMED NumberB-04560264530065 Basic UDI-DI 04560264530065UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264530065 UDI-DI Date16 Sep 2016ListedStatusListed 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 B-04560264530065 registered 13 Oct 2026 Active
  • FDA 510(k) K132264 decided 17 Dec 2013 Active
  • FDA GUDID UDI-DI 04560264530065 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132264
  2. Listed FDA GUDID 04560264530065
  3. Registered EUDAMED B-04560264530065

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Primado2
Generic name
Burring power tool attachment
Model / reference
P200-2AM
Primary DI / UDI-DI
04560264530065 EUDAMED
04560264560741 GUDID
Basic UDI-DI
B-04560264530065
FDA product code
HBC
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Burring power tool attachment
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4360
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04560264530065
GUDID
04560264560741
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 04560264530065; FDA GUDID lists 04560264560741), so their flags are not compared. 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.

Related devices

Category: Drilling power tool attachment, basicBurring 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 - OTHER.

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

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