LensHooke Sperm Separation Device
LensHooke Sperm Separation Device prepares motile sperm from semen for fertility procedures including ICSI, IVF and intrauterine insemination. It separates sperm by their ability to swim…
LensHooke Sperm Separation Device prepares motile sperm from semen for fertility procedures including ICSI, IVF and intrauterine insemination. It separates sperm by their ability to swim through filter layers into separation medium.
The device has a base and filter ports for medium loading and sperm collection. CA0 has one filter layer and CA1 has two. One milliliter of liquefied semen is loaded into the base.
Processing and Supply
The loaded device is incubated at 37 degrees Celsius for 30 minutes so motile sperm migrate into the upper layer. Separated sperm are collected through the filter port. Devices are individually packaged, radiation-sterilized and intended for single use.
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.
| 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
| Listed by | Bonraybio Co., Ltd., Taiwan |
|---|---|
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Manufacturer |
| 510(k) | K221810 |
| Record published | 2025-02-16 |
| Record revised | 2025-04-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C; Storage environment temperature 36 to 86 °F; Handling environment temperature 15 to 38 °C; Handling environment temperature 59 to 100 °F; Handling environment humidity up to 70 % RH |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CA1 Package-150 sets-US-BR | In distribution | ||
| CA0 Package-25 sets-US-BR | 25 | In distribution | |
| CA1 Package-25 sets-US-HT | 25 | In distribution | |
| CA1 Package-25 sets-US-BR | 25 | In distribution | |
| CA1 Package-150 sets-US-HT | In distribution | ||
| CA0 Package-150 sets-US-HT | In distribution | ||
| CA0 Package-150 sets-US-BR | In distribution | ||
| CA0 Package-150 sets-EN-CE | 150 | In distribution | |
| CA0 Package-25 sets-US-HT | 25 | In distribution |
Same 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 |
| 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 |
| Surelock | Allwin Medical Devices, Inc. | 5 |
Showing 12 of 102. All products under Labware, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221810 | 2022-10-31 |
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.