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FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device
EUDAMEDClass IVD General (EU MDR)
Ref MI-S45001
Identity
- Trade Name
- FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device EUDAMED
- Device Name
- FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device EUDAMED
- Model / Reference
- MI-S45001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804827137 EUDAMED
- Basic UDI-DI
- B-06952804827137 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER 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
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
FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device by Assure Tech. (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-06952804827137 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b4a1bdf0-79f2-43b3-b67c-89b5c943b84e 61 fields · synced Jul 23, 2026