Dental Root-Canal Instruments
by Shenzhen Perfect Medical Instruments Co., Ltd. China EUDAMED
Ref 55/.04Model EX-GOLD，TG6，EX-BLUE，EX，ET，RC，机用MTF，NXT(MTF PLUS)，TF4 GOLD，PX-ONE，GPH，etc. EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69590742NiTiRotaryVR | Date16 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- EX-GOLD，TG6，EX-BLUE，EX，ET，RC，机用MTF，NXT(MTF PLUS)，TF4 GOLD，PX-ONE，GPH，etc., 55/.04
- Primary DI / UDI-DI
- 06941422625515, 06941422625492, 06941422625485, 06941422625522, 06941422625508, 06941422625539
- Basic UDI-DI
- 69590742NiTiRotaryVR
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025529
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (6)
- EUDAMED 43ebe0fc-7fb4-418d-84ff-e543da02fdd1
- EUDAMED 06941422625492|69590742NITIROTARYVR
- EUDAMED 06941422625485|69590742NITIROTARYVR
- EUDAMED 06941422625522|69590742NITIROTARYVR
- EUDAMED 06941422625508|69590742NITIROTARYVR
- EUDAMED 06941422625539|69590742NITIROTARYVR