# Gatoson Holdings Ltd (The) · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 74 D - - XY Pulse-Generator, Pacemaker, Implantable _(verified: appears in the quote below)_
- **Product:** Pulse Generator; Pacemaker Implantable _(verified: appears in the quote below)_
- **FDA notes:** Class III; 4/14/2003 _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).