Hangzhou Singclean Medical Products Co Ltd · 89-08 · CHINA
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
- 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
- Economic & Technological Development Zon , No 125 (E) 10th Street, Hangzhoui , Hangzhou, Zhejiang CHINA verified
- Date published
- 04/28/2017 verified
- 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 each item verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html