Guangzhou Huada Biotechnology Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 9 device types.
Guangzhou Huada Biotechnology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Needle, Fistula, Surgeon’S Gloves and 7 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | GUANGZHOU HUADA BIOTECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010187826 |
| FEI number | 3010187826 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 广州华大生物科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No.84, Banhe Road,Guangzhou High-Tech Industrial Development Zone |
| Postal code | 510530 |
| 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 | EXU-DRY, Skintegrity Hydrogel Wound Dressing, Conformant 2 | 2026 | 118 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Electrosurgical pencil | 2017 | 65 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Drynet, Profore Wound Contact Layer | 2017 | 266 |
| Microtools, Assisted Reproduction (Pipettes) | Class 2 | Denudation Pipettes | 2026 | 2 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | Class 2 | Holding pipettes, Center well dish, Sperm CD, 35mm culture dish, Denuding pipettes, Holding pipettes for PGT and 7 more | 2024 | 8 |
| Needle, Fistula | Class 2 | Dora Disposable A.V. Fistula Needle Sets | 2020 | 4 |
| Surgeon’S Gloves | Class 1 | Surgical Gloves | 2022 | 10 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | IMPROVACUTER®Gel & Clot Activator Tube | 2013 | 23 |
| Wound Dressing With Animal-Derived Material(S) | Class U | Collagen Wound Dressing | 2025 | 12 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Main products | electron beam irradiation sterilization, gamma irradiation systems, sterilization equipment |
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.
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