← Back to catalogue
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref DA0201Model Single tube, 10 tests/kitRef DA0203Model Single tube, 20 tests/kit
Identity
- Device Name
- Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Single tube, 10 tests/kit EUDAMEDDA0201 EUDAMEDSingle tube, 20 tests/kit EUDAMEDDA0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103002018 EUDAMED06928103002032 EUDAMED
- Basic UDI-DI
- B-06928103002018 EUDAMEDB-06928103002032 EUDAMED
- EMDN Code
- W0105040505 RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing) by Daan Gene 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-06928103002018 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 25000b29-d39b-4ab4-88a6-fb83de8d62d9 61 fields · synced Jul 9, 2026
- EUDAMED 5586276e-11dd-4c16-b4be-f0e358d4277f 61 fields · synced May 19, 2026