Data / Medical devices / China / Shenzhen VitaVitro Biotech Co.,Ltd.
Shenzhen VitaVitro Biotech Co.,Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances
Shenzhen VitaVitro Biotech Co.,Ltd. is registered with the FDA (registration 3015140190) in Shenzhen Guangdong, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015140190
- Address
- R601, Building B, and 301, Area 02, Building A Hai Ke Xing Tech Park, Baoshan Road No.16, Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen VitaVitro Biotech Co.,Ltd. (10059112)
- Roles
- Manufacturer
- First device listed
- December 1, 2018
- Registered through
- 2026
- Brand names listed
- VitaVitro 1-Step Culture Medium, VitaVitro Embryo Transfer Catheter, VitaVitro Straw Set, VitaVitro Vitrification Kit, VitaVitro Warming Kit, VitaVitro® Double Lumen Oocyte Retrieval Needle, VitaVitro® Fertilization Medium, VitaVitro® Flushing Buffer Medium and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | 2 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction, Exempt | PUD | 2 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive, Exempt | QKI | 2 | Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 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 |
|---|---|---|---|---|---|---|
| November 15, 2024 | K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | MQE | Substantially Equivalent | Shenzhen Vitavitro Biotech Co., Ltd. | accessdata.fda.gov |
| August 16, 2024 | K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | MQF | Substantially Equivalent | Shenzhen Vitavitro Biotech Co., Ltd. | accessdata.fda.gov |
| February 1, 2022 | K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | MQL | Substantially Equivalent | Shenzhen Vitavitro Biotech Co., Ltd. | accessdata.fda.gov |
| October 16, 2020 | K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium | MQL | Substantially Equivalent | Shenzhen Vitavitro Biotech Co., Ltd. | accessdata.fda.gov |
| August 23, 2019 | K191063 | 1-Step Culture Medium | MQL | Substantially Equivalent | Shenzhen Vitavitro Biotech Co., Ltd. | accessdata.fda.gov |
| August 29, 2018 | K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | MQL | Substantially Equivalent | Shenzhen Vitavitro Bio-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Assisted Reproduction
- All makers of Catheter, Assisted Reproduction
- All makers of Media, Reproductive
- All makers of Labware, Assisted Reproduction
- All makers of Media, Reproductive, Exempt
- All makers of Labware, Assisted Reproduction, Exempt
Updated November 15, 2024. 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.