Xuchang Zhengde Environstar Medical Products Co., Ltd.
Manufacturer and brand owner in Xuchang, Henan, China. 7 device types, 5 products catalogued, 2 clearances.
Xuchang Zhengde Environstar Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bandage, Elastic, Non-Surgical Gown and 5 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
7device types registered with the FDA
5products catalogued under its own name
2510(k) clearances
Registration
| Registered name | XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009114792 |
| FEI number | 3009114792 |
| DUNS | 421272799 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 许昌正德医疗用品有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Xuchang |
|---|---|
| Province | Henan |
| Address | No.3 Weilai Road, Industry Cluster District, Yanling County |
| Postal code | 461200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 2013 | 439 | |
| Bandage, Elastic | Class 1 | Elastic Bandage | 2012 | 280 |
| Drape, Surgical, Exempt | Class 2 | 2019 | 107 | |
| Fiber, Medical, Absorbent | Class 1 | 2022 | 172 | |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze | 2012 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | 2012 | 67 | |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| ZD Isolation Gown-CP | OEA | 4 |
| Zhende SG-WR | FYA | 4 |
| ZD Isolation Gown-C | OEA | 2 |
| Covetrus | FYA | 1 |
| ZD | FYA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213893 | 2022-12-21 | FYA | Traditional | This company |
| K192290 | 2020-04-30 | FYA | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Zdeer Technology (Henan) Co., Ltd. | 9 |
| Xuchang Zhende Surgical Dressing Co., Ltd. | 6 |
| Henan Zhende Medical Products Co., Ltd. | 5 |
| Yanling Medtech Medical Products Co., Ltd. | 3 |
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.