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AS2000 B2/B3

by Nakanishi Inc. EUDAMEDGUDID

Active European Union

Ref T697Model AS2000 B2/3

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04560224977190 Basic UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560224977190 UDI-DIDate16 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD 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
Pneumatic dental scaling/debridement system handpiece
Model / Reference
AS2000 B2/3 EUDAMED
T697 EUDAMED
AS2000 B2/B3 GUDID
Primary DI / UDI-DI
04560224977190
Basic UDI-DI
B-04560224977190
510(k) Number
FDA Product Code
ELC
EMDN Code
Z12119001, Z12119080
GMDN Term
Pneumatic dental scaling/debridement system handpiece
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4850
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS2000 B2/3
T697
GUDID
AS2000 B2/B3
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Prescription Use
  • Serial Number

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
  • Expiration Date: No
  • Manufacturing Date: No