XL 5q31/5q33/5p15
Ref D-5081-100-TC
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number42513158D-5081IVDKT 04251315812222 | Date3 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- D-5081-100-TC
- Primary DI / UDI-DI
- 04251315812222
- Basic UDI-DI
- 42513158D-5081IVDKT
- EMDN Code
- W01060299 Tests for acquired genetic or chromosomal alterations - other
- Device Class
- Class C
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006315
Other devices from Metasystems Probes GmbH
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No