Cardiac Markers Control Plus
by Maccura Biotechnology Co., Ltd.
Ref IM4498075, IM4495075, IM4494075, IM4491075, IM4492075, IM4497075
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-IM4498075NA | Date22 May 2022 | 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- Withdrawn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
- Cardiac Markers Control Plus
- Model / Reference
- IM4498075, IM4495075, IM4494075, IM4491075, IM4492075, IM4497075
- Primary DI / UDI-DI
- D-IM4498075NA, D-IM4495075MM, D-IM4494075ME, D-IM4491075LR, D-IM4492075LY, D-IM4497075N3
- Basic UDI-DI
- B-IM4498075NA, B-IM4495075MM, B-IM4494075ME, B-IM4491075LR, B-IM4492075LY, B-IM4497075N3
- EMDN Code
- W0102152004 Cardiac marker controls
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Humiss International B.V. NL-AR-000001490
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (6)
- Sterile: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No