HGH CLIA Microparticles
by Autobio Diagnostics Co., Ltd. EUDAMED
Active
Ref CML0203Model AutoLumo Analyzer
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697015090000040GU | Date2 Aug 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- AutoLumo Analyzer, CML0203
- Primary DI / UDI-DI
- 06942359550994
- Basic UDI-DI
- 697015090000040GU
- EMDN Code
- W0102060402 Human growth hormone
- Device Class
- Class B
- Market of Registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000003348
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Autobio Diagnostics Co., Ltd.
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