INCYTO C-Chip
by INCYTO Co., Ltd. 8 variants
Ref DHC-N01-2Model Disposable Hemocytometer (INCYTO C-Chip)
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number88000239CHIPLF 08800023900033 | Date16 Dec 2024 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Disposable Hemocytometer (INCYTO C-Chip)
- Model / Reference
- Disposable Hemocytometer (INCYTO C-Chip), DHC-N01-2
- Primary DI / UDI-DI
- 08800023900033
- Basic UDI-DI
- 88000239CHIPLF
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000011868
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from INCYTO Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No