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Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR)
EUDAMEDClass IVD General (EU MDR)
Ref 0201002861Ref 0201002862Model 25 tests/kit
Identity
- Trade Name
- Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) EUDAMED
- Device Name
- Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) EUDAMEDNipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) EUDAMED
- Model / Reference
- 0201002861 EUDAMED25 tests/kit EUDAMED0201002862 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971140521318 EUDAMED06971140521325 EUDAMED
- Basic UDI-DI
- B-06971140521318 EUDAMEDB-06971140521325 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) by Beijing Kinghawk Pharmaceutical 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-06971140521318 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Kinghawk Pharmaceutical CO., Ltd
- EUDAMED SRN
- CN-MF-000052726
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 37ec1b69-6f2f-4369-965f-70ef9f4b25ed 61 fields · synced Jul 12, 2026
- EUDAMED 486e4025-1f01-47ba-b3b2-07d3aae23af1 61 fields · synced Jul 12, 2026