Hariomed Culture Dish

The Hariomed culture dish is intended for preparing, storing, and transferring human embryos. The Hariomed culture dish must be used together with the Harioculture TL-16 Time-lapse…

Registry build 21.09.26

The Hariomed culture dish is intended for preparing, storing, and transferring human embryos. The Hariomed culture dish must be used together with the Harioculture TL-16 Time-lapse Incubator.

10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MQK
Manufacturer City Province Registered as Device types
Shenzhen Boomingshing Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Dongguan King Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 14
Wuhan Huchuang Union Technology Co., Ltd. Wuhan Hubei Manufacturer 8
Shenzhen VitaVitro Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 7
HUA YUE Medical Technology Co., Ltd. Guangzhou Guangdong Manufacturer 7
CGN Gray (Shenzhen) Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Gimbo Medical Technology Shenzhen Co., Ltd. Shenzhen Guangdong Manufacturer 3
Guangzhou Hehong Biotech Co., Ltd. Guangzhou Guangdong Manufacturer 2
Shandong Wego Ruisheng Medical Device Co., Ltd. Weihai Shandong Manufacturer 2

Record

Regulatory record for Hariomed culture dish
Listed by HUA YUE Medical Technology Co., Ltd., China
FDA product code MQK
Device type Labware, Assisted Reproduction
Device class Class 2
Regulation 21 CFR 884.6160
Establishment Manufacturer
510(k) K242684
Record published 2025-09-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store at room temperature
Packaging Pack of 20, pack of 5

Catalogue Numbers

Catalogue numbers for Hariomed culture dish
Catalogue number Size Status
TLdish-2*8 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cryotec Reprolife Inc. 20
VitriGuard Origio A/S 16
G-Vitri™ Vitrification Straw Gimbo Medical Technology Shenzhen Co., Ltd. 15
ZyMot DxNow Inc. 10
LensHooke Sperm Separation Device Bonraybio Co., Ltd. 9
cryo-GO Vitrification Device Fujifilm Irvine Scientific 9
LifeGlobal® GPS® Dishware Coopersurgical, Inc. 7
LifeGlobal® GPS® Dishware LifeGlobal Group, LLC 7
Nest VT Cook Incorporated 5
Surestrip Allwin Medical Devices, Inc. 5
Minvitro Vitrification Straw Guangzhou Hehong Biotech Co., Ltd. 5
Rapid-i Kit Vitrolife Sweden AB 5

Showing 12 of 102. All products under Labware, Assisted Reproduction

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