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Sign in to claim this brandGimbo Medical Technology Shenzhen Co., Ltd.
US
Last updated May 25, 2026
What Gimbo Medical Technology Shenzhen Co., Ltd. makes
Gimbo Medical Technology Shenzhen Co., Ltd. produces media and cryostorage solutions for assisted reproductive technology, including IVF culture media (such as cleavage and blastocyst stages), warming and vitrification media, gamete buffers, and cryopreservation straws for tissue storage. Their portfolio also includes flushing and retrieval media for oocytes, as well as single-step culture media for embryo development.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gimbo Medical Technology Shenzhen Co., Ltd. manufacture?
Gimbo Medical Technology Shenzhen Co., Ltd. specializes in producing media and cryostorage solutions primarily used in assisted reproductive technology (ART). Their portfolio includes IVF culture media for different developmental stages (such as cleavage and blastocyst), warming and vitrification media for embryo preservation, gamete buffers for sperm and egg handling, and cryostorage straws for tissue cryopreservation. They also offer flushing and retrieval media for oocytes and single-step culture media designed to support embryo development throughout the IVF process.
Where is Gimbo Medical Technology Shenzhen Co., Ltd. based?
The company is based in the United States. While its name includes 'Shenzhen,' the operational headquarters and regulatory presence are established in the US, where its devices are developed and marketed.
In which regulatory registries are Gimbo Medical Technology’s devices listed?
Gimbo Medical Technology’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways for Class II medical devices in the US.
How are Gimbo Medical Technology’s devices classified under FDA regulations?
All of Gimbo Medical Technology’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 722458269
Catalogue (56)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Giftlife™ Cleavage Medium | CM10 | FDA UDI | Class II | Active |
| Giftlife™ Blastocyst Medium | BM30 | FDA UDI | Class II | Active |
| G-Vitri™ Warming media | TDW10.0 | FDA UDI | Class II | Active |
| Gamete Buffer | GB60 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-A-G | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-A-R | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | BEV10.0 | FDA UDI | Class II | Active |
| Oocyte Flushing & Retrieval Medium | ORRM500 | FDA UDI | Class II | Active |
| Oocyte Flushing & Retrieval Medium | ORRM125 | FDA UDI | Class II | Active |
| Single Step Medium Plus | EM60 | FDA UDI | Class II | Active |
| Gamete Buffer | GB500 | FDA UDI | Class II | Active |
| G-Vitri™ Warming media | TDW5.0 | FDA UDI | Class II | Active |
| Gamete Buffer | GB125 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SC-C-G | FDA UDI | Class II | Active |
| Giftlife™ Fertilization Medium | FM60 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | EV5.0 | FDA UDI | Class II | Active |
| Sperm Freezing Medium | SFM30 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-B-Y | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-B-R | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SC-C-Y | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-B-O | FDA UDI | Class II | Active |
| Gamete Buffer | GB250 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-A-O | FDA UDI | Class II | Active |
| Giftlife™ Fertilization Medium | FM30 | FDA UDI | Class II | Active |
| Giftlife™ Blastocyst Medium | BM60 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-A-B | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SC-C-B | FDA UDI | Class II | Active |
| Sperm Freezing Medium | SFM10 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | BEV5.0 | FDA UDI | Class II | Active |
| Giftlife™ Fertilization Medium | FM10 | FDA UDI | Class II | Active |
| G-Vitri™ Warming media | TDW4.0 | FDA UDI | Class II | Active |
| Giftlife™ Cleavage Medium | CM30 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | BEV1.5 | FDA UDI | Class II | Active |
| Giftlife™ Cleavage Medium | CM60 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-A-Y | FDA UDI | Class II | Active |
| Giftlife™ Single Step Medium | SSM30 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-B-B | FDA UDI | Class II | Active |
| G-Vitri™ Warming media | TDW1.0 | FDA UDI | Class II | Active |
| Oocyte Flushing & Retrieval Medium | ORRM60 | FDA UDI | Class II | Active |
| Giftlife™ Single Step Medium | SSM10 | FDA UDI | Class II | Active |
| Giftlife™ Blastocyst Medium | BM10 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | BEV1.0 | FDA UDI | Class II | Active |
| Oocyte Flushing & Retrieval Medium | ORRM250 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | EV10.0 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SC-C-O | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SC-C-R | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification Straw | SP-B-G | FDA UDI | Class II | Active |
| Giftlife™ Single Step Medium | SSM60 | FDA UDI | Class II | Active |
| Single Step Medium Plus | EM30 | FDA UDI | Class II | Active |
| G-Vitri™ Vitrification media | EV1.0 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Gimbo Medical Technology Shenzhen Co., Ltd. Shenzhen Guangdong · CN FEI 3030681110