NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials
by NORMA Instruments Zártkörűen Működő Részvénytársaság
Ref NIC-032K1Model NormaCont3+ KIT K1
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 | Number59991062NormaCont36B 05999106200122 | Date5 Feb 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- Withdrawn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
- NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers
- Model / Reference
- NormaCont3+ KIT K1, NIC-032K1
- Primary DI / UDI-DI
- 05999106200122
- Basic UDI-DI
- 59991062NormaCont36B
- EMDN Code
- W0103010503 Multilevel blood controls
- Device Class
- Class A
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- HU-MF-000014244
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Properties
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No