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Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)
EUDAMEDClass IVD General (EU MDR)
Ref F03006A-48
Identity
- Device Name
- Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA) EUDAMED
- Model / Reference
- F03006A-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440976 EUDAMED
- Basic UDI-DI
- B-06975102440976 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
Mpox Virus Nucleic Acid Detection Kit（Fluorescent 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-06975102440976 | 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 (1)
- EUDAMED 6c536e56-b614-49cf-9678-908c75fbb0e4 61 fields · synced Jun 18, 2026