Reference Source

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

For Guangdong Haiou Medical Apparatus Co., Ltd, import alert is 89-08; country is CHINA; 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)"; product is Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm) | Disposable sterile needle retractable safety syringe 1mL 25G 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 2026-09-30.

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 23G x 1inch (25mm) | Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm) each item verified
FDA notes
Needle Retractable Safety Syringe; model 1mL 23G x 1inch (25mm) dimensions subject to DWPE | Needle Retractable Safety Syringe; model 1mL 25G 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

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

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 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

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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