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Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)
EUDAMEDClass IVD General (EU MDR)
Ref F03R01A-24Ref F03R01A-48
Identity
- Device Name
- Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification) EUDAMED
- Model / Reference
- F03R01A-24 EUDAMEDF03R01A-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440471 EUDAMED06975102440464 EUDAMED
- Basic UDI-DI
- B-06975102440471 EUDAMEDB-06975102440464 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
Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification) by Jiangsu Qitian Gene biotechnology 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-06975102440471 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 52fe7eb1-4e9d-47d5-b928-52ea74feece1 61 fields · synced Oct 6, 2026
- EUDAMED 60a25751-57ee-44e1-b925-203c9e0ebfd3 61 fields · synced May 17, 2026