Insertion aid long
Ref 3060Model Tools Is
Active
CE MDR CE MDD
Valid until
15 Jul 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number4057982TOOLS1SCB | Date6 Oct 2026 | StatusActive |
| European Union | CE/MDR | Number4057982TOOLS1SCB | Date6 Oct 2026 | StatusActive |
Certificates
- 1000316605 Active
Quality management system EU MDR
- Notified body
- DQS Medizinprodukte GmbH 0297
- Issued
- 16 Jul 2026
- Expires
- 15 Jul 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Champions Tools sterileTools
- Model / Reference
- 3060, Tools Is
- Primary DI / UDI-DI
- 04057982002641
- Basic UDI-DI
- 4057982TOOLS1SCB, B-04057982002641
- EMDN Code
- P01020180 Dental implants - accessories
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000008148
Other devices from Champions-Implants GmbH
Properties
Other properties (12)
- 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