# Hangzhou Singclean Medical Products Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Hangzhou Singclean Medical Products 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 Singfiller Cross-linked Sodium Hyaluronate Gel | Singfiller Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING GEL | Singfiller Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING GEL | Singfiller Cross-linked Sodium Hyaluronate Gel; product code is 53 P H - 99 Other Cosmetic Raw Materials, N.E.C., Powder | 53 P Y - 99 Other Cosmetic Raw Materials, N.E.C., Not Elsewhere Classified (NEC) | 78 M - - RE Solution, Sodium Hyaluronate | 78 M - - RE Solution, Sodium Hyaluronate | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 04/28/2017; address is Economic & Technological Development Zon , No 125 (E) 10th Street, Hangzhoui , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** Hangzhou Singclean Medical Products 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:** Economic & Technological Development Zon , No 125 (E) 10th Street, Hangzhoui , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 04/28/2017 _(verified: appears in the quote below)_
- **Product code:** 53 P H - 99 Other Cosmetic Raw Materials, N.E.C., Powder | 53 P Y - 99 Other Cosmetic Raw Materials, N.E.C., Not Elsewhere Classified (NEC) | 78 M - - RE Solution, Sodium Hyaluronate | 78 M - - RE Solution, Sodium Hyaluronate | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use _(verified: each item appears in the quote below)_
- **Product:** Singfiller Cross-linked Sodium Hyaluronate Gel | Singfiller Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING GEL | Singfiller Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING GEL | Singfiller Cross-linked Sodium Hyaluronate Gel _(verified: each item appears in the quote below)_
- **FDA notes:** Class III device without a PMA | Class III device without a PMA | Class III device without a PMA | Class III device without a PMA | Class III device without a PMA | Class III device without a PMA _(verified: each item appears in the quote below)_

## What the source says

> Hangzhou Singclean Medical Products Co Ltd Date Published : 04/28/2017 Economic & Technological Development Zon , No 125 (E) 10th Street, Hangzhoui , Hangzhou, Zhejiang CHINA 53 P H - 99 Other Cosmetic Raw Materials, N.E.C., Powder Date Published: 04/28/2017 Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA 53 P Y - 99 Other Cosmetic Raw Materials, N.E.C., Not Elsewhere Classified (NEC) Date Published: 04/28/2017 Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA 78 M - - RE Solution, Sodium Hyaluronate Date Published: 06/04/2019 Desc: SINGFILLER ANTI-AGING GEL Notes: Class III device without a PMA 78 M - - RE Solution, Sodium Hyaluronate Date Published: 04/28/2017 Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 06/04/2019 Desc: SINGFILLER ANTI-AGING GEL Notes: Class III device without a PMA 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/28/2017 Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a 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/).