# Guangzhou Xiubo Medical Equipment Co. Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Xiubo Medical Equipment 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 OTESALY Cross-linked Hyaluronic Acid w/lidocaine | OTESALY Cross-linked Hyaluronic Acid w/lidocaine; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 04/06/2017; address is No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Xiubo Medical Equipment Co. Ltd _(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:** No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/06/2017 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: each item appears in the quote below)_
- **Product:** OTESALY Cross-linked Hyaluronic Acid w/lidocaine | OTESALY Cross-linked Hyaluronic Acid w/lidocaine _(verified: each item appears in the quote below)_
- **FDA notes:** Class III device without a premarket approval (PMA) | Class III device without a premarket approval (PMA) _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Xiubo Medical Equipment Co. Ltd Date Published : 04/06/2017 No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/06/2017 Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA) 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/06/2017 Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA)

## 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/).