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SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncyt…
EUDAMEDClass IVD General (EU MDR)
Ref 106-0057-01Model 12 reactions/kit
Identity
- Device Name
- SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncytial Virus Diagnostic Kit EUDAMED
- Model / Reference
- 12 reactions/kit EUDAMED106-0057-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447582126 EUDAMED
- Basic UDI-DI
- B-06975447582126 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncyt… by Igenesis(Shanghai)Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975447582126 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6fccf22b-29db-4f3f-8eae-52643e132eb9 61 fields · synced Jun 18, 2026