Bioregen Biomedical (Changzhou) Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 2 device types.
Bioregen Biomedical (Changzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Splint, Intranasal Septal, Dressing, Wound, Hydrogel Without Drug And/Or Biologic. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007327621 |
| FEI number | 3007327621 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 常州百瑞吉生物医药股份有限公司 |
|---|---|
| Unified social credit code | 91320412675465930M |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | Building B, No. 117, Xueye Road |
| Postal code | 213125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | HealoRegen Gel | 2015 | 118 |
| Splint, Intranasal Septal | Class 1 | PureRegen Gel Sinus | 2008 | 3 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 200+ |
| Main products | PureRegen Gel, MateRegen Gel, HyaRegen Gel, Drug sustained release agents, VitRegen |
| Certifications | GMP, ISO13485, CE, Class III medical device approval |
| Export markets | 50+ countries |
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.