Endostep
by Shanwei Perfect Medical Instruments Co., Ltd. EUDAMED 179 variants
Active
Ref Z490 201 932 3104 045、Z490 201 932 3104 060、Z490 201 932 3104 090Model 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- Withdrawn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 covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Dental Root-Canal Instruments
- Model / Reference
- ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, Z490 201 932 3104 045、Z490 201 932 3104 060、Z490 201 932 3104 090
- Primary DI / UDI-DI
- 06942200936540
- 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
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