Endodontic Files
by Changzhou Sifary Medical Technology Co., Ltd. United States EUDAMED
Ref 5181701Model E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX
EMDN L159004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6126956CE01 | Date31 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 6126956CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 31 Mar 2025
- Expires
- 1 Aug 2027
- Reason
- Change approved
Specification
- Model / Reference
- E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX, 5181701
- Primary DI / UDI-DI
- 06941877809171
- Basic UDI-DI
- 697259778EF001KX
- EMDN Code
- L159004 Endodontic rasps and files, reusable
- Device Class
- Class IIa
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000010405
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Changzhou Sifary Medical Technology Co., Ltd.
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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 (1)
- EUDAMED d97aec09-8322-4c7f-8910-1da085c1cdad