← Back to catalogue
Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic …
EUDAMEDClass IVD General (EU MDR)
Ref IS-FZ-029-24-1Model 24 tests/kit
Identity
- Trade Name
- Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) EUDAMED
- Device Name
- Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) EUDAMED
- Model / Reference
- 24 tests/kit EUDAMEDIS-FZ-029-24-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974677694630 EUDAMED
- Basic UDI-DI
- B-06974677694630 EUDAMED
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic … by Shanghai BioGerm Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-06974677694630 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018164
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 09739888-2519-46b6-a9e0-4c9bb5d43a31 61 fields · synced Jun 19, 2026