SpermFreeze

SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product…

Registry build 21.09.26

SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)

4manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(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 SpermFreeze
Listed by Fertipro NV, Belgium
FDA product code MQL
Device type Media, Reproductive
Device class Class 2
Regulation 21 CFR 884.6180
510(k) K053494
Record published 2016-05-24
Record revised 2024-06-24 (version 5)

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
Storage Special storage condition: Keep away from sunlight; Storage environment temperature 2 to 8 °C
Packaging Pack of 25, pack of 5
Sizes Total volume 5 to 20 ml

Catalogue Numbers

Catalogue numbers for SpermFreeze
Catalogue number Size Status
SPF05 Total Volume 5 ml In distribution
SPF Total Volume 20 ml 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
K242640 2025-05-30
K070135 2007-08-16
K053494 2006-03-23

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer