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20001327

by Nakanishi Inc.

Ref 20001327Model MDA0000148

20001327 is a device classified as Class I in the EU and Class II in the US made by Nakanishi Inc., registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI 45602249800001487J), cleared under FDA 510(k) K073678 on 10 Jul 2008 and listed in FDA GUDID since 8 Apr 2026 (UDI-DI 04589551386758), active as of 23 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K073678

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number45602249800001487J Basic UDI-DI 04589551386758UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04589551386758 UDI-DI Date8 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK073678 Date10 Jul 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45602249800001487J registered 4 Sep 2026 Active
  • FDA 510(k) K073678 decided 10 Jul 2008 Active
  • FDA GUDID UDI-DI 04589551386758 listed 8 Apr 2026 Listed

Recalls

1 recall · FDA

    • Terminated Z-2673-2016 FDA Class II initiated 8 Jul 2016

    Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.

Timeline

4 dated events

  1. Cleared FDA 510(k) K073678
  2. Recall initiated FDA recalls Z-2673-2016
  3. Listed FDA GUDID 04589551386758
  4. Registered EUDAMED 45602249800001487J

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
Va-Sg-Tip Holder
Generic name
Instrument tray, reusable
Model / reference
MDA0000148 EUDAMED
20001327 EUDAMED
VA-SG-TIP HOLDER GUDID
Primary DI / UDI-DI
04589551386758
Basic UDI-DI
45602249800001487J
Direct marketing DI
04589551387205
510(k) Number
FDA product code
ELC, DZI
EMDN code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.4850, 872.4120
EU registration type
Standard device
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
Model / referenceEUDAMED
MDA0000148
20001327
GUDID
VA-SG-TIP HOLDER
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.

Manufacturer details

EUDAMED SRN
JP-MF-000011271
Authorised representative
NSK Europe GmbH DE-AR-000007040

Similar devices in this category

Other devices filed under DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER.

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)