← Back to catalogue
KaiBiLi Extended ViralTrans
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K231027
Identifiers
- 510(k) Number
- K231027 FDA 510(k)
- FDA Product Code
- JSM FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2390 FDA 510(k)
- Regulation Number
- 866.2390 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
KaiBiLi Extended ViralTrans by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K231027 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- FDA Applicant
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
Sources (2)
- FDA 510(k) K231027 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026