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Dental High Speed Turbine Handpiece

by Guangdong JINME Medical Technology Co., Ltd. 14 variants

Ref TUPModel 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. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971119540180 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697111954HSHQN Basic UDI-DI 06971119540180UDI-DIDate20 Sep 2023RegisteredStatusActive

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 22 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  • Withdrawn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

Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic
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, TUP
Primary DI / UDI-DI
06971119540180
Basic UDI-DI
697111954HSHQN
Direct Marketing DI
06971119540180
510(k) Number
FDA Product Code
EFB
EMDN Code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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