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Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）
EUDAMEDClass IVD General (EU MDR)
Ref F03R10AⅢ-24Ref F03R10AⅢ-48
Identity
- Device Name
- Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA） EUDAMED
- Model / Reference
- F03R10AⅢ-24 EUDAMEDF03R10AⅢ-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102441072 EUDAMED06975102441065 EUDAMED
- Basic UDI-DI
- B-06975102441072 EUDAMEDB-06975102441065 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
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
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA） by Jiangsu Qitian Gene biotechnology 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-06975102441072 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (2)
- EUDAMED 8b1cc3b1-c1cb-414d-9be5-3f8bf6753f36 61 fields · synced Jul 23, 2026
- EUDAMED 292f54dc-3a37-4377-b2ca-27dbf4474fae 61 fields · synced May 18, 2026