RAMP D-dimer
Ref C1106Model RAMP D-dimer (C1106)
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-10627966005053 10627966005053 | Date17 Sep 2026 | 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- Withdrawn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/IVDD Active
Specification
- Model / Reference
- RAMP D-dimer (C1106), C1106
- Primary DI / UDI-DI
- 10627966005053
- Basic UDI-DI
- B-10627966005053
- EMDN Code
- W0103020503 D-dimer
- Device Class
- Class IVD General
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CA-MF-000034747
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Response Biomedical Corp.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No