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SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT
EUDAMEDClass B (EU MDR)
Ref RTPCR021
by Vircell, S.L
Identity
- Trade Name
- SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT EUDAMED
- Device Name
- SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT EUDAMED
- Model / Reference
- RTPCR021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436040329900 EUDAMED
- Basic UDI-DI
- 843604032RTPCR02101VJ EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT by Vircell, S.L — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843604032RTPCR02101VJ | Class B | Active |
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Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED 689c8371-0987-4b45-b1b3-f449d860c1c0 61 fields · synced Jun 20, 2026