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Strep B Rapid Test Dipstick Cardiac Troponin T Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref ISB-501
Identity
- Trade Name
- Strep B Rapid Test Dipstick Cardiac Troponin T Test Cassette EUDAMED
- Device Name
- Strep B Rapid Test Dipstick EUDAMED
- Model / Reference
- ISB-501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ISB-501SA EUDAMED
- Basic UDI-DI
- B-ISB-501SA EUDAMED
- EMDN Code
- W0105090104 STREP. B - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Strep B Rapid Test Dipstick Cardiac Troponin T Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ISB-501SA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cef88bd4-66be-40e3-9d10-e81d2a4955e5 61 fields · synced Jun 14, 2026