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Water Filter Set (4m)

by Nakanishi Inc. EUDAMEDGUDID

Active European Union

Ref U1007080Model MDA0000128

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04560264535213 UDI-DIDate1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number45602249800001287C Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Reference
MDA0000128 EUDAMED
U1007080 EUDAMED
Water Filter Set (4m) GUDID
Primary DI / UDI-DI
04560264535213
Basic UDI-DI
45602249800001287C
FDA Product Code
ELC
EMDN Code
Z12119080 Various dental stomatology instruments - hardware accessories
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.4850
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MDA0000128
U1007080
GUDID
Water Filter Set (4m)
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No