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Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)
EUDAMEDClass IVD General (EU MDR)
Ref F03R05A-96Ref F03R05A-24Ref F03R05A-48
Identity
- Device Name
- Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification) EUDAMED
- Model / Reference
- F03R05A-96 EUDAMEDF03R05A-24 EUDAMEDF03R05A-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440488 EUDAMED06975102440501 EUDAMED06975102440495 EUDAMED
- Basic UDI-DI
- B-06975102440488 EUDAMEDB-06975102440501 EUDAMEDB-06975102440495 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
Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification) 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-06975102440488 | 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 (3)
- EUDAMED 818c446b-b12c-4be2-9ee1-fd0989e89bb6 61 fields · synced Jul 23, 2026
- EUDAMED 499cc8a8-13d5-482c-9366-ee9549827f30 61 fields · synced May 17, 2026
- EUDAMED 1b703c20-caa1-470a-a066-d1682e040eda 61 fields · synced May 19, 2026