Guangdong Haiou Medical Apparatus Co., Ltd.
Puning, CN
Guangdong Haiou Medical Apparatus Co., Ltd. appears in FDA device records in Puning, CN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Guangdong Haiou Medical Apparatus Co., Ltd. in 2021.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1507-2022 | Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25 | Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user | Class II | Open, Classified | |
| Z-1506-2022 | HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25 | Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain