Data / Medical devices / China / Gimbo Medical Technology Shenzhen Co., Ltd.
Gimbo Medical Technology Shenzhen Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Gimbo Medical Technology Shenzhen Co., Ltd. is registered with the FDA (registration 3030681110) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 15, 2026. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030681110
- Address
- 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Provinc, Shenzhen Guangdong, China, 518107
- Owner or operator
- Gimbo Medical Technology Shenzhen Co., Ltd. (10088612)
- Roles
- Manufacturer
- First device listed
- February 29, 2024
- Registered through
- 2026
- Brand names listed
- G-Vitri Vitrification Straw, G-vitri Vitrification media; G-vitri Warming media, Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle, Giftlife Blastocyst Medium, Giftlife Cleavage Medium, Giftlife Fertilization Medium, Giftlife Single Step Medium, Giftlife® Single-Step Medium Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | MQE | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| January 8, 2025 | K242043 | Sperm Freezing Medium | MQL | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| November 22, 2024 | K242968 | Giftlife® Single-Step Medium Plus | MQL | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| June 14, 2024 | K240002 | G-Vitri Vitrification Straw | MQK | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| June 13, 2024 | K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | MQL | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| May 10, 2024 | K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | MQL | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| January 30, 2024 | K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | MQL | Substantially Equivalent | Gimbo Medical Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Needle, Assisted Reproduction
- All makers of Labware, Assisted Reproduction
Updated June 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.