← Back to catalogue
SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip…
EUDAMEDClass IVD General (EU MDR)
Ref 12 tests/kit
Identity
- Device Name
- SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method) EUDAMED
- Model / Reference
- 12 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450626 EUDAMED
- Basic UDI-DI
- B-06972221450626 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS 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
SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip… 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-06972221450626 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9998af32-85cb-4e83-a421-e2fb2ae087b6 61 fields · synced Jun 19, 2026