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Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-EV016AModel 50tests/kitRef HWTS-EV016BModel 10 tests/kit
Identity
- Trade Name
- Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) EUDAMED
- Device Name
- Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDHWTS-EV016A EUDAMED10 tests/kit EUDAMEDHWTS-EV016B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366051 EUDAMED06974849366044 EUDAMED
- Basic UDI-DI
- B-06974849366051 EUDAMEDB-06974849366044 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…
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-06974849366051 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d4428c50-c572-49b6-acda-f239c909f74c 61 fields · synced Sep 18, 2026
- EUDAMED 9f8b441c-6e8a-4c93-8513-2e6e4e3c2d2f 61 fields · synced May 19, 2026