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Dental High Speed Turbine Handpiece

by Guangdong JINME Medical Technology Co., Ltd. 25 variants

Ref J2-204Model J6-126/J6-136/J1-004/J1 PLUS-004/J3 PLUS-004/J2-214/J2-204/J4-014/J5-214/J5-204/J45-204/Y1-004/Y3-004/A1-004/A2-04/A3-004/A4-004/F8-004/RED60-26/T/SU/TU/TUP/TUQP/SUQP/45-TUQ

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170229↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697111954HSHQN Basic UDI-DI 06971119540647UDI-DIDate20 Sep 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK170229 Date8 Nov 2017IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
J6-126/J6-136/J1-004/J1 PLUS-004/J3 PLUS-004/J2-214/J2-204/J4-014/J5-214/J5-204/J45-204/Y1-004/Y3-004/A1-004/A2-04/A3-004/A4-004/F8-004/RED60-26/T/SU/TU/TUP/TUQP/SUQP/45-TUQ, J2-204
Primary DI / UDI-DI
06971119540647
Basic UDI-DI
697111954HSHQN
Direct Marketing DI
06971119540647
EMDN Code
Z12110180 Instruments for dental treatment units - hardware accessories
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033806
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangdong JINME Medical Technology Co., Ltd.

See all devices from Guangdong JINME Medical Technology Co., Ltd. →

Properties

Other properties (13)

  • Sterile: 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