Who else makes this device?

Name: Hyaluronidase 80 U/mL
Brand: Hyaluronidase 80 U/mL

Hyaluronidase 80 U/mL · Media, Reproductive → Obstetrics & Gynecology

4manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

10recalls on this 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 Hyaluronidase 80 U/mL
Listed by	Coopersurgical, Inc., United States
FDA product code	MQL
Device type	Media, Reproductive
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2017-03-28
Record revised	2025-09-26 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Hyaluronidase 80 U/mL
Catalogue number	Size	Per pack	Status
ART-4007-A		6	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
K173731	2018-03-02
K170560	2017-04-04

Recalls

8 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2024-02-16	Class II	Under Investigation by firm	Low concentration of sodium pyruvate in the wash could compromise gamete development	980 units
2024-02-16	Class II	Under Investigation by firm	Low concentration of sodium pyruvate in the wash could compromise gamete development	2680 units
2024-02-16	Class II	Under Investigation by firm	Low concentration of sodium pyruvate in the wash could compromise gamete development	770 units
2023-12-20	Class II	Under Investigation by firm	The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.	994 total (481 US; 513 OUS)
2023-02-13	Class II	Labeling Change Control	It has come to CooperSurgical’s attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.	190 units
2022-12-15	Class II	Labeling Change Control	The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.	489 units
2022-06-13	Class II	Error in labeling	There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.	403 units
2020-09-08	Class II	Under Investigation by firm	There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrificati	531 total boxes	2021-01-11
2016-08-25	Class III	Packaging change control	Products contain international package insert and not the correct USA package insert	1 unit	2017-02-01
2016-08-25	Class III	Packaging change control	Products contain international package insert and not the correct USA package insert	4 units	2017-02-01

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.

Hyaluronidase 80 U/mL