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Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence R…
EUDAMEDClass B (EU MDR)
Ref BSJ04S1Model BSJ04S1, BSJ04M1, BSJ04L1Ref BSJ04M1Ref 101A0201EY,101A0201ED
Identity
- Trade Name
- Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) EUDAMED
- Device Name
- Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) EUDAMEDInfluenza A/B Virus Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- BSJ04S1, BSJ04M1, BSJ04L1 EUDAMEDBSJ04S1 EUDAMEDBSJ04M1 EUDAMED101A0201EY,101A0201ED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227931 EUDAMED06973843227924 EUDAMEDD-697603130101A0201EG7SK EUDAMED
- Basic UDI-DI
- 697384322BSJ04JG EUDAMEDB-697603130101A0201EG7SK EUDAMED
- Direct Marketing DI
- 06973843227931 EUDAMED06973843227924 EUDAMED
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS EUDAMEDW0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Greece EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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
Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence R… by Hangzhou Bioer Technology Co., Ltd. — Class B — IVDD, IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697384322BSJ04JG | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 697384322BSJ04JG | Class B | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 9c5f9dd3-2b24-4fb4-93c4-9a90135408b7 61 fields · synced Jul 30, 2026
- EUDAMED 5ea59e64-5911-481d-ac54-6097980dfaa4 61 fields · synced May 18, 2026
- EUDAMED 35a75b52-24a9-4b7e-96b8-6d17410de6ec-1 61 fields · synced Jul 25, 2026
- EUDAMED 35a75b52-24a9-4b7e-96b8-6d17410de6ec-2 61 fields · synced Jul 25, 2026