Perfect
by Shenzhen Perfect Medical Instruments Co., Ltd.
Model Super File(MTF), To&Fro,Mone File,Keen File,Multi Taper,DK/DH File,MG3,MG3II,S-BLUE,etc, EX-GOLD,TG6,EX-BLUE,EX,ET,RC,机用MTF,NXT(MTF PLUS),TF4 GOLD,PX-ONE,GPH,etc.Ref EX-GOLD,15/.04
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69590742NiTiRotaryfilesUY 06959074200004 | Date8 Mar 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- PerfectDental Root-Canal Instruments
- Model / Reference
- Super File(MTF), To&Fro, Mone File, Keen File, Multi Taper, DK/DH File, MG3, MG3II, S-BLUE,etc, EX-GOLD,TG6,EX-BLUE,EX,ET,RC,机用MTF,NXT(MTF PLUS),TF4 GOLD,PX-ONE,GPH,etc., EX-GOLD, 15/.04
- Primary DI / UDI-DI
- 06959074200004
- Basic UDI-DI
- 69590742NiTiRotaryfilesUY, 69590742NiTiRotaryVR
- EMDN Code
- Q01010299, Q010507
- Device Class
- Class IIa
- EU market of registration
- IrelandGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025529
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Perfect Medical Instruments Co., Ltd.
See all devices from Shenzhen Perfect Medical Instruments 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