HongYu BioTech (ShenZhen) Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 15 device types.
HongYu BioTech (ShenZhen) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cover, Cast, Dilator, Nasal and 13 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | HongYu BioTech (ShenZhen) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017107376 |
| FEI number | 3017107376 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 红雨生物科技（深圳）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | NO.806, Finance Center, NO.22 Taizi Road, Shuiwan Community, Zhaoshang Street |
| Postal code | 518067 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Shower Safety Seating | 2023 | 193 |
| Cover, Cast | Class 1 | Cast Cover | 2024 | 31 |
| Dilator, Nasal | Class 1 | Nasal strips | 2023 | 55 |
| Disinfectant, Medical Devices | Class 1 | Medical Devices, Alcohol Prep Pad/Cleansing Pads, Disinfectant | 2020 | 197 |
| Dressing, Wound, Drug | Class U | Silver Alginate Dressing | 2023 | 48 |
| Dressing, Wound, Hydrophilic | Class 1 | Hydrocolloid Gel Bandages, Transparent Film Dressing, Alginate Dressings, Film Island Dressing, Non-woven Adhesive Wound Dressing with pad,, Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne Patch, | 2020 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Trap Door Dressing (NAD Dressing, wound, occlusive), Silicone Contact Layer, Petrolatum Gauze Dressing | 2020 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Hydrophilic wound dressing, Scar Gel, silicone scar sheet, Silicone Tape, Silicone Gel Sheeting, Silicone Dressing | 2020 | 85 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | PVA Sponges, PVA Swabs, PVA Bandages | 2020 | 266 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Medical compression sock | 2023 | 76 |
| Strip, Adhesive, Closure, Skin | Class 1 | Wound Closure Strip | 2024 | 14 |
| Tape And Bandage, Adhesive | Class 1 | Non-woven Tape; non-woven surgical tape; PE Tape; transparent surgical tape; I.V Dressing; Silicone Tape, Surgical Tape; Foam Tape PVC; Elastic Bandages; Athletic Tape; Bandage | 2020 | 353 |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | Cane | 2023 | 69 |
| Walker, Mechanical | Class 1 | Folding Walker | 2023 | 183 |
| Wound Dressing With Animal-Derived Material(S) | Class U | Collagen Dressing | 2026 | 12 |
Clearances
No clearance names HongYu BioTech (ShenZhen) Co., Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K253974 | 2026-06-03 | KGN | Traditional | Roosin Medical Co., Ltd. |
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.