Skip to content

NSK Sterile Burs/Drills PDS-2EFUL-40M

by Nakanishi Inc.

Ref PDS-2EFUL-40MModel MDA0000026

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number456022498000002673 Basic UDI-DI 04589551366569UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04589551366569 UDI-DI Date8 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
NSK Sterile Burs/Drills
Generic Name
Orthopaedic bur, single-use
Model / Reference
PDS-2EFUL-40M, MDA0000026
Primary DI / UDI-DI
04589551366569
Basic UDI-DI
456022498000002673
510(k) Number
FDA Product Code
EQJ, ERL, GFF, HBE
EMDN Code
V0199 Cutting devices, single-use - other
GMDN Term
Orthopaedic bur, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.4140, 874.4250, 878.4820, 882.4310
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Cleared under the same submission (K202120)

Show all (12)

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No