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SARS-CoV-2/Flu A/FIu B Ag
EUDAMEDClass IVD General (EU MDR)
Ref VLD01-03-13 Model VLD01
Identity
- Trade Name
- SARS-CoV-2/Flu A/FIu B Ag EUDAMED
- Device Name
- SARS-CoV-2/Flu A/FIu BAg Rapid Test VLD01-03-13 EUDAMED
- Model / Reference
- VLD01 EUDAMEDVLD01-03-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VLD0136 EUDAMED
- Basic UDI-DI
- B-VLD0136 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
SARS-CoV-2/Flu A/FIu B Ag 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-VLD0136 | 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 (1)
- EUDAMED bba6a98a-5b57-4c9a-8bee-20528bb2b7a8 61 fields · synced Jun 19, 2026