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Strep A Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VIST-701Ref VIST-702Model VIST
Identity
- Trade Name
- Strep A Rapid Test EUDAMEDStrep A Test EUDAMED
- Device Name
- Strep A Rapid Test EUDAMEDStrep A Test EUDAMED
- Model / Reference
- VIST-701 EUDAMEDVIST EUDAMEDVIST-702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIST-701WK EUDAMED06937339204950 EUDAMED06937339204967 EUDAMED06937339209542 EUDAMED
- Basic UDI-DI
- B-VIST-701WK EUDAMEDB-06937339204950 EUDAMEDB-06937339204967 EUDAMEDB-06937339209542 EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Strep A Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-VIST-701WK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED ea0d1460-484c-4104-8729-245d9a508b5d 61 fields · synced Oct 7, 2026
- EUDAMED e0ec9f23-3c85-486d-900a-93914885b424 61 fields · synced May 18, 2026
- EUDAMED 7ae36f4d-20ff-4f87-8b29-459fb90b2b6b 61 fields · synced May 19, 2026
- EUDAMED 063bb6ac-678c-4051-a02d-cae7c1d0862f 61 fields · synced Jul 17, 2026