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Influenza A/Influenza B/RSV Nucleic Acid Test Card
EUDAMEDClass IVD General (EU MDR)
Ref RM1010402-10
Identity
- Device Name
- Influenza A/Influenza B/RSV Nucleic Acid Test Card EUDAMED
- Model / Reference
- RM1010402-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975327120196 EUDAMED
- Basic UDI-DI
- B-06975327120196 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
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
Influenza A/Influenza B/RSV Nucleic Acid Test Card by Guangzhou Pluslife Biotech 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-06975327120196 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025784
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 5f9c9253-8225-4be5-8b93-0c35ca6f14a8 61 fields · synced Oct 6, 2026