Beijing Biosis Healing Biological Technology Co., Ltd.
Registered establishment in Beijing, China. 7 device types.
Beijing Biosis Healing Biological Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Non-Surgical Gown, Staple, Implantable and 5 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016668451 |
| FEI number | 3016668451 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京博辉瑞进生物科技股份有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | 1-2F Building 1&2,No.29 Yongda Road,Daxing Bio-medicine Industry Base,Daxing District |
| Postal code | 102600 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Medical Goggle, Medical Face Shield, Protective Goggle | 2020 | 439 |
| Barrier, Animal Source, Intraoral | Class 2 | Oral Matrix | 2025 | 2 |
| Cover, Shoe, Operating-Room | Class 1 | Medical Shoe cover | 2020 | 176 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Medical Face Mask | 2020 | 182 |
| Laparoscope, General & Plastic Surgery | Class 2 | Disposable Laparoscope Trocar | 2022 | 46 |
| Non-Surgical Gown | Class 1 | Isolation Gowns, Medical Protective clothing | 2020 | 318 |
| Staple, Implantable | Class 2 | Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable, Disposable Hemorrhoidal Stapler, Disposable Circular Staple, Endoscopic Linear Cutter Stapler and Reloads | 2022 | 16 |
Clearances
No clearance names Beijing Biosis Healing Biological Technology Co., Ltd. as applicant. 3 are 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 |
|---|---|---|---|---|
| K231513 | 2024-02-16 | NPL | Traditional | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. |
| K201639 | 2021-05-27 | GDW | Traditional | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. |
| K201641 | 2020-08-06 | GCJ | Traditional | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | SIS biomaterials, Hernia repair products, Oral surgery membranes, Neurosurgery repair products |
| Certifications | National High-tech Enterprise, National Specialized and Sophisticated Little Giant Enterprise, ANVISA GMP, Hong Kong MDACS IV |
| Export markets | Hong Kong, Brazil, Vietnam, Southeast Asia |
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.