Shenzhen VitaVitro Biotech Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 7 device types, 7 products catalogued, 5 clearances.
Shenzhen VitaVitro Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Media, Reproductive, Media, Reproductive, Exempt and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | Shenzhen VitaVitro Biotech Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015140190 |
| FEI number | 3015140190 |
| DUNS | 544504573 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳韦拓生物科技有限公司 |
|---|---|
| Unified social credit code | 914403003591865500 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | R601, Building B, and 301, Area 02, Building A |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Assisted Reproduction | Class 2 | VitaVitro Embryo Transfer Catheter | 2024 | 5 |
| Labware, Assisted Reproduction | Class 2 | VitaVitro Straw Set, VitaVitro Warming Kit, VitaVitro Vitrification Kit | 2018 | 10 |
| Labware, Assisted Reproduction, Exempt | Class 2 | 2022 | 7 | |
| Media, Reproductive | Class 2 | VitaVitro® Sperm Gradient Medium, VitaVitro® Sperm Washing Medium, VitaVitro® Flushing Buffer Medium, VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro 1-Step Culture Medium and 3 more | 2018 | 4 |
| Media, Reproductive, Exempt | Class 2 | 2022 | 2 | |
| Microtools, Assisted Reproduction (Pipettes), Exempt | Class 2 | 2022 | 8 | |
| Needle, Assisted Reproduction | Class 2 | VitaVitro® Double Lumen Oocyte Retrieval Needle, VitaVitro® Single Lumen Oocyte Retrieval Needle | 2024 | 3 |
Own-Brand Listings
Clearances
5 clearances name Shenzhen VitaVitro Biotech Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240523 | 2024-11-15 | MQE | Traditional | This company |
| K240307 | 2024-08-16 | MQF | Traditional | This company |
| K212410 | 2022-02-01 | MQL | Traditional | This company |
| K200408 | 2020-10-16 | MQL | Traditional | This company |
| K191063 | 2019-08-23 | MQL | Traditional | This company |
| K180073 | 2018-08-29 | MQL | Traditional | Shenzhen Vitavitro Bio-Tech Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Vitrification and warming kits, Culture medium, Fertilization medium, Embryo transfer catheter |
| Certifications | ISO 13485 |
| Export markets | Global |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.