Yocon Biology Technology Company
Registered establishment in Haidian, Beijing, China. 2 device types, 1 clearance.
Yocon Biology Technology Company is a manufacturer holding a current FDA establishment registration. The registration covers Applicator, Absorbent Tipped, Sterile, Media, Culture, Ex Vivo, Tissue And Cell. Its earliest product listing with the FDA dates from 2020.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | YOCON BIOLOGY TECHNOLOGY COMPANY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016633010 |
| FEI number | 3016633010 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 友康生物科技（北京）股份有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Haidian |
|---|---|
| Province | Beijing |
| Address | 304, Third Floor, A Building, No.7 Fengxian Middle Road |
| Postal code | 100094 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | Speimen Collection Swabs, Flocked Swabs | 2020 | 100 |
| Media, Culture, Ex Vivo, Tissue And Cell | Class 2 | MSC SFM, MSC SFM Basal Medium and MSC SFM supplement | 2024 | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232543 | 2024-09-06 | NDS | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Factory area | 42,000 m² |
| Main products | Serum-free cell culture media, Molecular diagnostic products, Cell culture bags, Virus sampling kits, Automatic sample workstation |
| Certifications | ISO 9001, ISO 13485, FDA registration, Zhongguancun high-tech enterprise, National high-tech enterprise |
| Export markets | Over 40 countries including North America, South America, Australia, Middle East, Canada |
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.