Fibrin and Fibrinogen Degradation Products Assay
by Medcaptain Medical Technology Co., Ltd. 8 variants
Ref MCC00702E
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-06926802603109 06926802603109 | Date30 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- Withdrawn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
- Device Name
- Fibrin and Fibrinogen Degradation Products Assay
- Model / Reference
- MCC00702E
- Primary DI / UDI-DI
- 06926802603109
- Basic UDI-DI
- B-06926802603109
- EMDN Code
- W0103020502 Fibrinogen degradation products
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000005925
- Authorised representative
- R Sight B.V. NL-AR-000010445
Other devices from Medcaptain Medical Technology Co., Ltd.
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Properties
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No