Henan Robestain Medical Products Co., Ltd.
Registered establishment in Changyuan, Henan, China. 5 device types, 1 clearance.
Henan Robestain Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Gown, Surgical, Dress, Surgical and 3 other device types. Its earliest product listing with the FDA dates from 2020.
5device types registered with the FDA
1510(k) clearance
Registration
| Registered name | HENAN ROBESTAIN MEDICAL PRODUCTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017195371 |
| FEI number | 3017195371 |
| Establishment type | Manufacturer |
Location
| City | Changyuan |
|---|---|
| Province | Henan |
| Address | No.590,Zhangnan IndustryZone,Zhangsanzhai Town |
| Postal code | 453440 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Henan Robestain Medical | 2020 | 439 |
| Drape, Surgical, Exempt | Class 2 | Henan Robestain Medical | 2023 | 107 |
| Dress, Surgical | Class 1 | Henan Robestain Medical | 2020 | 71 |
| Gown, Surgical | Class 2 | Henan Robestain Medical | 2021 | 68 |
| Non-Surgical Gown | Class 1 | Henan Robestain Medical | 2020 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212925 | 2021-12-13 | FYA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Surgical drapes, Surgical gowns, Surgical packs |
| Certifications | ISO 9001, ISO 13485, CE |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Henan Yadu Industrial Co., Ltd. | 35 |
| Yadu Medical (Henan) Co., Ltd. | 30 |
| Evereast Medical Products Group Co., Ltd. | 30 |
| Henan Maidingkang Medical Technology Co., Ltd. | 7 |
| Henan Tuoren Medical Device Co., Ltd. | 5 |
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.