Spreaders
by Shanwei Perfect Medical Instruments Co., Ltd. China EUDAMED
Ref J4906509822802015、J4906509822802020、J4906509822802025、J4906509822802030、J4906509822802035、J4906509822802040Model Pluggers(NITI)，Spreaders(NITI)
EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697590932NiTiCompactor99 | Date16 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental Root-Canal Instruments
- Model / Reference
- Pluggers(NITI)，Spreaders(NITI), J4906509822802015、J4906509822802020、J4906509822802025、J4906509822802030、J4906509822802035、J4906509822802040
- Primary DI / UDI-DI
- 06942200956807
- Basic UDI-DI
- 697590932NiTiCompactor99
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanwei Perfect Medical Instruments Co., Ltd.
See all devices from Shanwei Perfect Medical Instruments Co., Ltd. →
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 (1)
- EUDAMED 06942200956807|697590932NITICOMPACTOR99