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Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)
EUDAMEDClass IVD General (EU MDR)
Ref F03R12A-24Ref F03014A-96
Identity
- Device Name
- Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification) EUDAMED
- Model / Reference
- F03R12A-24 EUDAMEDF03014A-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440532 EUDAMED06975102440518 EUDAMED
- Basic UDI-DI
- B-06975102440532 EUDAMEDB-06975102440518 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
Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification) by Jiangsu Qitian Gene biotechnology Co., Ltd — Class IVD General — IVDD…
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-06975102440532 | 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 3927fd62-2ef1-4526-b4e8-273673b76ee7 61 fields · synced Jul 14, 2026
- EUDAMED 221212ff-f020-44c1-b94b-47e986cd1492 61 fields · synced May 18, 2026