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Influenza A/B+COVID-19/RSV Combo Ag Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HWP292-01Model Cassette
by CorDx, Inc.
Identity
- Trade Name
- Influenza A/B+COVID-19/RSV Combo Ag Test EUDAMED
- Device Name
- Influenza A/B+COVID-19/RSV Combo Ag Test EUDAMED
- Model / Reference
- Cassette EUDAMEDHWP292-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850067912569 EUDAMED
- Basic UDI-DI
- B-00850067912569 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Influenza A/B+COVID-19/RSV Combo Ag Test by CorDx, Inc. — Class IVD devices for self-testing — 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-00850067912569 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- CorDx, Inc.
- EUDAMED SRN
- US-MF-000029255
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED eadb5494-431c-48e7-9f99-ba64fba13e6c 61 fields · synced Jun 18, 2026