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Generic name: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 96 tests/kitModel 96 tests/kitRef 32 tests/kit
Identity
- Device Name
- Generic name: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 96 tests/kit EUDAMED32 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450701 EUDAMED06972221450695 EUDAMED
- Basic UDI-DI
- B-06972221450701 EUDAMEDB-06972221450695 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
Generic name: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method) by CapitalBio Technology (Chengdu) Co., Ltd. — Class IVD General — IVDD — listed…
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-06972221450701 | 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 (2)
- EUDAMED e9725f31-8455-4b83-a5ce-c95ef66bc63a 61 fields · synced Sep 18, 2026
- EUDAMED e3946691-20fb-4d15-8f69-e09c9d866461 61 fields · synced May 18, 2026