Haptoglobin Assay Kit (Immunoturbidimetric Method)
by Maccura Biotechnology Co., Ltd. 9 variants
Ref CH0192319Model CH0102319 CH0100319 CH0801319 CH0800319 CH0802319 CH0803319 CH0804319 CH0191319 CH0192319
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 | Number69506174CH08031979 06950617450771 | Date16 Oct 2026 | 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- Withdrawn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
- CH0102319 CH0100319 CH0801319 CH0800319 CH0802319 CH0803319 CH0804319 CH0191319 CH0192319, CH0192319
- Primary DI / UDI-DI
- 06950617450771
- Basic UDI-DI
- 69506174CH08031979
- Direct Marketing DI
- 06950617450771
- EMDN Code
- W0102010302 Haptoglobin
- Device Class
- Class B
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No