Who else makes this device?

Name: V-Grad 100
Brand: V-Grad 100

Obstetrics & Gynecology › MiscellaneousMedia, Reproductive

V-Grad 100

V-GRAD 100 is a stock solution used to prepare a density-gradient system for separating motile sperm from ejaculates in assisted reproduction procedures. It is the 100 percent stock…

Registry build 21.09.26

V-GRAD 100 is a stock solution used to prepare a density-gradient system for separating motile sperm from ejaculates in assisted reproduction procedures. It is the 100 percent stock formulation in the V-GRAD range, distinct from the diluted ready-to-use solutions.

The medium is a colloidal suspension of silicate particles stabilized with covalently bound hydrophilic silanes. The density-gradient method uses this suspension as the separation medium during semen preparation. V-GRAD is intended for prescription use.

Storage

The aseptically filtered solution is supplied in presterilized bottles. It has a one-year shelf life when stored at 2 to 8 degrees Celsius and can be used for up to seven days after the bottle is opened.

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 100
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
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for V-Grad 100
Catalogue number	Size	Status
V-GRD00_100P		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.