Xuchang Zhengde Environstar Medical Products Co.,Ltd.
Xuchang Henan, CN
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD. appears in FDA device records in Xuchang Henan, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Xuchang Zhengde Environstar Medical Products Co.,Ltd. between 2020 and 2022. The busiest year on record is 2020, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213893 | Comfort Gown, Safewear Gown | FYA | Substantially Equivalent | |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009114792 | 3009114792 | XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,LTD. | No.3 Weilai Road, Industry Cluster District, Yanling County, Xuchang Henan 461200 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain