TRACE4AD™
by DeepTrace Technologies S.R.L. EUDAMED
Active
Ref 019
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805201514TRACE4ADCLv2.52Z | Date28 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- IT352911 Issued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 22 May 2026
- Expires
- 21 May 2031
Specification
- Device Name
- TRACE4AD
- Model / Reference
- 019
- Primary DI / UDI-DI
- 08052015140198
- Basic UDI-DI
- 805201514TRACE4ADCLv2.52Z
- Direct Marketing DI
- 08052015140198
- EMDN Code
- Z11069082 Various digital bioimaging management instruments - software accessories
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027591
Other devices from DeepTrace Technologies S.R.L.
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