Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4410040Model IM4410040 IM4411040 IM4414040 IM4415040
EMDN W0105010899
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-IM4410040H7 | Date22 May 2022 | StatusActive |
| European Union | CE/IVDD | NumberB-IM4410040H7 | Date22 May 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device Name
- Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit
- Model / Reference
- IM4410040, IM4410040 IM4411040 IM4414040 IM4415040
- Primary DI / UDI-DI
- D-IM4410040H7, 06950617416784
- Basic UDI-DI
- B-IM4410040H7, 69506174IM441040D7
- Direct Marketing DI
- 06950617416784
- EMDN Code
- W0105010899, W0105010802
- Device Class
- Class IVD GeneralClass B
- 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 & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 56b23d28-2c02-49b9-ab64-46f5e2afee8b
- EUDAMED 06950617416784|69506174IM441040D7