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KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref ARV-IRef ARV-IIRef ARV-III
Identity
- Trade Name
- KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) EUDAMED
- Device Name
- Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) EUDAMED
- Model / Reference
- ARV-I EUDAMEDARV-II EUDAMEDARV-III EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360767 EUDAMED06974735360392 EUDAMED06974735360620 EUDAMED
- Basic UDI-DI
- B-06974735360767 EUDAMEDB-06974735360392 EUDAMEDB-06974735360620 EUDAMED
- EMDN Code
- W0105040606 ROTAVIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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
KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed in…
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-06974735360767 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 3ca58420-9078-48b0-a94f-704517d79e22 61 fields · synced Jul 25, 2026
- EUDAMED dc1d7429-1451-4547-9b83-56f55940e780 61 fields · synced May 17, 2026
- EUDAMED 1e256405-02cb-4ae2-9faf-b1b9f56f8f04 61 fields · synced May 18, 2026