Reference Source

Guangdong Haiou Medical Apparatus Co., Ltd · 89-08 · CHINA

For Guangdong Haiou Medical Apparatus Co., Ltd · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm) | Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm); product code is 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick; date published is 04/30/2021; address is Nanyuan Industrial , Liushazhen Puning , Jieyang, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Guangdong Haiou Medical Apparatus Co., Ltd verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
CHINA verified
Address
Nanyuan Industrial , Liushazhen Puning , Jieyang, Guangdong CHINA verified
Date published
04/30/2021 verified
Product code
80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick each item verified
Product
Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm) | Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm) each item verified
FDA notes
Needle Retractable Safety Syringe; model 1mL 25G x 1inch (25mm) dimensions subject to DWPE | Needle Retractable Safety Syringe; model 1mL 23G x 1inch (25mm) dimensions subject to DWPE each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Guangdong Haiou Medical Apparatus Co., Ltd Date Published : 04/30/2021 Nanyuan Industrial , Liushazhen Puning , Jieyang, Guangdong CHINA 80 M - - EG Syringe, Antistick Date Published: 04/30/2021 Desc: Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm) Notes: Needle Retractable Safety Syringe; model 1mL 25G x 1inch (25mm) dimensions subject to DWPE 80 M - - EG Syringe, Antistick Date Published: 04/30/2021 Desc: Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm) Notes: Needle Retractable Safety Syringe; model 1mL 23G x 1inch (25mm) dimensions subject to DWPE

accessdata.fda.gov, retrieved 2026-09-15

Source

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