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KEYU Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref RV/ADV-IIIRef RV/ADV-IIRef RV/ADV-I
Identity
- Trade Name
- KEYU Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold) EUDAMED
- Device Name
- Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- RV/ADV-III EUDAMEDRV/ADV-II EUDAMEDRV/ADV-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360637 EUDAMED06974735360408 EUDAMED06974735360774 EUDAMED
- Basic UDI-DI
- B-06974735360637 EUDAMEDB-06974735360408 EUDAMEDB-06974735360774 EUDAMED
- EMDN Code
- W0105040601,W0105040606 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 Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold) 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-06974735360637 | 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 06c61004-f3bb-406c-841c-b12211bac725 61 fields · synced Jul 19, 2026
- EUDAMED f786c37f-b5e4-40b8-88c3-44a62a122b9b 61 fields · synced May 18, 2026
- EUDAMED 74c49fb1-04b1-42de-8fa7-92d16bf3e8c0 61 fields · synced May 19, 2026