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Strep A Rapid Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref IST-502Ref ISTB-N502H-07
Identity
- Trade Name
- Strep A Rapid Test Cassette EUDAMEDStrep A Rapid Test EUDAMED
- Device Name
- Strep A Rapid Test Cassette EUDAMEDStrep A Rapid Test EUDAMED
- Model / Reference
- IST-502 EUDAMEDISTB-N502H-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983188661 EUDAMED06936983178013 EUDAMED
- Basic UDI-DI
- B-06936983188661 EUDAMED6970277510014PYS EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Ireland EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Strep A Rapid Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06936983188661 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06936983188661 | 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 (3)
- EUDAMED 0f22924d-e016-47fe-9efc-e26da5542a59 61 fields · synced Aug 1, 2026
- EUDAMED 7ec41f3e-3d34-4eb6-82b8-557481005767 61 fields · synced Jul 8, 2026
- EUDAMED 4048ba79-6591-4441-967d-06d21182dcb2 61 fields · synced Aug 1, 2026