FlexiS
by Shanwei Perfect Medical Instruments Co., Ltd. EUDAMED
Active
Ref Z498 201 904 2506 021Model ET Files、V BLUE、MTF、TG6、TH6、TF4 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697590932NiTiRotary96 | Date23 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental Root-Canal Instruments
- Model / Reference
- ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, Z498 201 904 2506 021
- Primary DI / UDI-DI
- 06942200972449
- Basic UDI-DI
- 697590932NiTiRotary96
- 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-000033003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Show 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