Who else makes this device?

Name: V-Grad 80 (2x for V-Grad Kit)
Brand: V-Grad 80 (2x for V-Grad Kit)

Obstetrics & Gynecology › MiscellaneousMedia, Reproductive

V-Grad 80 (2x for V-Grad Kit)

V-GRAD 80 is a ready-to-use density gradient medium for separating motile sperm from ejaculates during assisted reproduction procedures. It is the 80% solution in the V-GRAD range and can…

Registry build 21.09.26

V-GRAD 80 is a ready-to-use density gradient medium for separating motile sperm from ejaculates during assisted reproduction procedures. It is the 80% solution in the V-GRAD range and can be used with the corresponding gradient preparation system.

The sterile colloidal suspension contains silicate particles stabilized with hydrophilic silanes in HEPES-buffered human tubal fluid medium. Density gradient separation uses these media to prepare a sperm fraction for subsequent laboratory procedures.

Storage and Open Bottles

V-GRAD is prepared by aseptic filtration. Store the medium at 2 to 8°C; its unopened shelf life is one year. An opened bottle may be used for up to seven days.

4manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (3), Shandong (1).

Chinese manufacturers registered for FDA product code MQL
Manufacturer	City	Province	Registered as	Device types
Dongguan King Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Shenzhen VitaVitro Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7
Gimbo Medical Technology Shenzhen Co., Ltd.	Shenzhen	Guangdong	Manufacturer	3
Shandong Wego Ruisheng Medical Device Co., Ltd.	Weihai	Shandong	Manufacturer	2

Record

Regulatory record for V-Grad 80 (2x for V-Grad Kit)
Listed by	Vitromed GmbH, Germany
FDA product code	MQL
Device type	Media, Reproductive
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K241833
Record published	2025-07-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 2

Catalogue Numbers

Catalogue numbers for V-Grad 80 (2x for V-Grad Kit)
Catalogue number	Size	Status
V-GRD83_12G		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LifeGlobal® Media	LifeGlobal Group, LLC	93
Sydney IVF	William A. Cook Australia PTY, Ltd.	29
LifeGlobal® Media	Coopersurgical, Inc.	27
VitaVitro	Shenzhen VitaVitro Biotech Co., Ltd.	22
Nidacon	Nidacon International AB	19
Sil-Select Plus Lower Layer	Fertipro NV	8
FertiCult Mineral Oil	Fertipro NV	8
Dewin	Donnevie Medical Technology (Shanghai) Co., Ltd.	8
SpermGrad	Vitrolife Sweden AB	8
Sequential Culture Media	Kitazato Corporation	8
Sperm Wash Medium	Invitrocare Inc	7
Enhance-S Plus	Vitrolife Inc.	7

Showing 12 of 360. All products under Media, Reproductive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241833	2025-03-21
K240176	2024-09-13
K232125	2024-03-20
K222606	2023-05-26
K223117	2023-01-31
K193285	2020-11-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.