Dental High Speed Turbine Handpiece
by Guangdong JINME Medical Technology Co., Ltd. 14 variants
Ref TUQPModel 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
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06971119540142 | Date15 Jul 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number697111954HSHQN 06971119540142 | Date20 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 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, TUQP
- Primary DI / UDI-DI
- 06971119540142
- Basic UDI-DI
- 697111954HSHQN
- Direct Marketing DI
- 06971119540142
- 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 EUDAMEDClass 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
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | 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
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