Ama Struv
by «Association of Medicine and Analytics» Company Limited Russia EUDAMED
Ref 0501Model AMA STRUV
EMDN W0104010702
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-4680008050501VMFF | Date29 Sep 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Enzymatic express-test for the microbe-associated kidney stone disease (AMA STRUV)
- Model / Reference
- AMA STRUV, 0501
- Primary DI / UDI-DI
- D-4680008050501VMFF
- Basic UDI-DI
- B-4680008050501VMFF
- EMDN Code
- W0104010702 Urine screening manual - strips, etc.)
- Device Class
- Class IVD General
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- RU-MF-000036645
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties & raw data
Show properties, registry sources and raw records
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
- Surgical Instrument: No
Sources (1)
- EUDAMED cb52e28a-f4cc-4554-a9de-63890031fe22