FDA Registration
Active
🇨🇳 China
Shenzhen VitaVitro Biotech Co.,Ltd.
Reg #: 3015140190
·
FEI: 3015140190
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Shenzhen VitaVitro Biotech Co.,Ltd.
- Registration Number
- 3015140190
- FEI Number
- 3015140190
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- R601, Building B, and 301, Area 02, Building A, Hai Ke Xing Tech Park, Baoshan Road No.16, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212410
Owner / Operator
- Firm Name
- Shenzhen VitaVitro Biotech Co.,Ltd.
- Operator Number
- 10059112
- Address
- R601, Building B, Hai Ke Xing Tech Park, Pingshan District, Baoshan Road No.16
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2022-02-08 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2022-12-19 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2024-12-03 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2022-12-19 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2024-08-23 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2018-12-01 |
| Media, Reproductive, Exempt | QKI | Class 2 | Obstetrics/Gynecology | No | 2022-12-19 |
Proprietary Names
VitaVitro® Sperm Gradient Medium
VitaVitro® Sperm Washing Medium
VitaVitro® Double Lumen Oocyte Retrieval Needle
VitaVitro® Single Lumen Oocyte Retrieval Needle
VitaVitro Embryo Transfer Catheter
VitaVitro Warming Kit
VitaVitro Vitrification Kit
VitaVitro Straw Set
VitaVitro 1-Step Culture Medium
VitaVitro® Flushing Buffer Medium
VitaVitro® Gamete Buffer Medium
VitaVitro® Fertilization Medium
Establishment Types
Manufacture Medical Device