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Respiratory Pathogens Nucleic Acid Detection Kit (Isothermal Amplification on D…
EUDAMEDClass IVD General (EU MDR)
Ref 12 tests/kit
Identity
- Device Name
- Respiratory Pathogens Nucleic Acid Detection Kit (Isothermal Amplification on Disk Chip) EUDAMED
- Model / Reference
- 12 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450503 EUDAMED
- Basic UDI-DI
- B-06972221450503 EUDAMED
- EMDN Code
- W0105010902,W0105011102,W0105011203,W0105011610,W0105011699 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Respiratory Pathogens Nucleic Acid Detection Kit (Isothermal Amplification on D… by CapitalBio Technology (Chengdu) 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-06972221450503 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 92e418f7-d797-448f-ac58-0c73edb85876 61 fields · synced Jun 18, 2026