oncotrace
Ref 3.10
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-oncotraceLT D-oncotraceLT | Date29 Sep 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- 3.10
- Primary DI / UDI-DI
- D-oncotraceLT
- Basic UDI-DI
- B-oncotraceLT
- EMDN Code
- Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
- Device Class
- Class I
- Special Device Type
- -1192
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000034314
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No