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Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluores…
EUDAMEDClass B (EU MDR)
Ref BSJ05L1Model BSJ05S1, BSJ05M1, BSJ05L1 Ref BSJ05S1
Identity
- Trade Name
- Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) EUDAMED
- Device Name
- Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT-PCR) EUDAMED
- Model / Reference
- BSJ05S1, BSJ05M1, BSJ05L1 EUDAMEDBSJ05L1 EUDAMEDBSJ05S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227818 EUDAMED06973843227900 EUDAMED
- Basic UDI-DI
- 697384322BSJ05JJ EUDAMED
- Direct Marketing DI
- 06973843227818 EUDAMED06973843227900 EUDAMED
- EMDN Code
- W0105040505 RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluores… by Hangzhou Bioer Technology Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322BSJ05JJ | 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 (2)
- EUDAMED 8997530a-8e36-4f46-8b6a-fb49c26dabbf 61 fields · synced Jul 25, 2026
- EUDAMED bb948d05-21fa-4ba8-8da5-501e4dfc4a23 61 fields · synced May 19, 2026