Gems Vitrification Set

FDA UDI

Class II (US FDA UDI)

by Genea Biomedx Pty Ltd

Identity

Trade Name: Gems Vitrification Set FDA UDI
Generic Name: IVF medium FDA UDI
Model / Reference: VIT-01 FDA UDI

Identifiers

Primary DI / UDI-DI: 09348265006032 FDA UDI
510(k) Number: K162409 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium

Gems Vitrification Set by Genea Biomedx Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as IVF medium.

SPERMCARE Upper Layer - Gradient System — INVITROCARE, INCORPORATED · Class II
DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd · Class II
Sepa Sperm Solution — KITAZATO CORPORATION · Class II
LifeGlobal® Media — LifeGlobal Group, LLC · Class II
Multipurpose Handling Medium®-Complete (MHM®-C) — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
CaseBioscience® — Casebioscience, Inc. · Class II
SpermFreeze SSP — Fertipro NV · Class II
Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II

Cleared under the same submission

K162409 also covers:

Gems Warming Set — GENEA BIOMEDX PTY LTD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Genea Biomedx Pty Ltd

Sources (1)

FDA UDI 94a23d6a-d7f4-4433-81af-c97c087cbe9f 34 fields · synced Jun 1, 2026