Surestrip
SURESTRIP Vitrification Straw - Yellow colour
10manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Allwin Medical Devices, Inc., United States |
|---|---|
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K203626 |
| Record published | 2023-07-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, box packing of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SURESTRIP Vitrification Straw | In distribution | |
| SURESTRIP Vitrification Straw | In distribution | |
| SURESTRIP Vitrification Straw | In distribution | |
| SURESTRIP Vitrification Straw | In distribution | |
| SURESTRIP Vitrification Straw | 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 |
| 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 |
| 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 |
|---|---|
| K203626 | 2021-06-04 |
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.