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YouSeq SARS-CoV-2 Multiplex qRT-PCR kit
EUDAMEDClass IVD General (EU MDR)
Ref YS-qPX-CVD19-002-CE
by YouSeq Ltd
Identity
- Device Name
- YouSeq SARS-CoV-2 Multiplex qRT-PCR kit EUDAMED
- Model / Reference
- YS-qPX-CVD19-002-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060972700006 EUDAMED
- Basic UDI-DI
- B-05060972700006 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
YouSeq SARS-CoV-2 Multiplex qRT-PCR kit by YouSeq 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-05060972700006 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- YouSeq Ltd
- EUDAMED SRN
- GB-MF-000033902
- Authorised Representative
- Casus Consulting Limited IE-AR-000023507
Sources (1)
- EUDAMED a6910c7c-2a90-4e45-990b-9cd84577dc65 61 fields · synced Jun 19, 2026