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Varios VA970 LUX(120V)

by Nakanishi Inc.

Ref Y1001166Model VA970 LUX (120V)

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04560264518872 Basic UDI-DI 04560264518872UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264518872 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not 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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Varios
Generic Name
Ultrasonic dental scaling/debridement system
Model / Reference
VA970 LUX (120V) EUDAMED
Y1001166 EUDAMED
VA970 LUX(120V) GUDID
Primary DI / UDI-DI
04560264518872
Basic UDI-DI
B-04560264518872
510(k) Number
FDA Product Code
ELC
EMDN Code
S0199, Z12119001, Z12119080
GMDN Term
Ultrasonic dental scaling/debridement system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4850
EU 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
VA970 LUX (120V)
Y1001166
GUDID
VA970 LUX(120V)
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K113530)

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Other devices from Nakanishi Inc.

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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