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Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 mor…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251637

by DonneVie Medical Technology(Shanghai)Co.Ltd

Identifiers

510(k) Number
K251637 FDA 510(k)
FDA Product Code
MQL FDA 510(k)
Models / Variants
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] FDA 510(k)
Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) 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)

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 mor… by DonneVie Medical Technology(Shanghai)Co.Ltd — Class II — FDA_510K — listed…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
DonneVie Medical Technology(Shanghai)Co.Ltd
FDA Applicant
Donnevie Medical Technology (Shanghai) Co. , Ltd.

Sources (1)

  • FDA 510(k) K251637 24 fields · synced Jun 18, 2026