Vit Kit Freeze NX and Vit Kit Warm NX
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190152 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vit Kit Freeze NX and Vit Kit Warm NX are classified as Media, Reproductive, designed for the preservation and handling of reproductive cells and tissues. These kits provide controlled environments for vitrification (freezing) and warming (thawing) processes, essential for cryopreservation in assisted reproductive technologies.
Each kit is intended for single-use and includes sterile components for use in clinical settings, adhering to FDA 510(k) clearance and MDD authorization. Supplied as a complete system, the kits require proper storage at specified temperatures and are regulated under the Medical Specialty Description Obstetrics/Gynecology and Regulation Number 884.6180. No MRI safety information or reusable components are indicated in the specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190152 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
Sources (2)
- FDA 510(k) K190152 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026