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Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR As…
EUDAMEDClass IVD General (EU MDR)
Ref R231T050B0C0Ref R231T032B0C0
Identity
- Device Name
- Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay) EUDAMED
- Model / Reference
- R231T050B0C0 EUDAMEDR231T032B0C0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895476126 EUDAMED06970895476119 EUDAMED
- Basic UDI-DI
- B-06970895476126 EUDAMEDB-06970895476119 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR As… by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in…
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-06970895476126 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7d0a72ab-2bd7-458f-b128-30ddd5854caa 61 fields · synced Sep 30, 2026
- EUDAMED bb125d97-ea93-4ebf-b9c0-bce744b1da44 61 fields · synced May 19, 2026