Reference Source

Gatoson Holdings Ltd (The) · 89-08 · CHINA

For Gatoson Holdings Ltd (The) · 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 Pulse Generator; Pacemaker Implantable; product code is 74 D - - XY Pulse-Generator, Pacemaker, Implantable; date published is 09/16/2009; address is One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA, verified against its source on 2026-09-16.

Firm
Gatoson Holdings Ltd (The) 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
One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA verified
Date published
09/16/2009 verified
Product code
74 D - - XY Pulse-Generator, Pacemaker, Implantable verified
Product
Pulse Generator; Pacemaker Implantable verified
FDA notes
Class III; 4/14/2003 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Gatoson Holdings Ltd (The) Date Published : 09/16/2009 One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA 74 D - - XY Pulse-Generator, Pacemaker, Implantable Date Published: 01/23/2019 Desc: Pulse Generator; Pacemaker Implantable Notes: Class III; 4/14/2003

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

Source

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