Hangzhou Singclean Medical Products Co Ltd · 89-08 · CHINA
For Hangzhou Singclean Medical Products Co Ltd, import alert is 89-08; country is CHINA; 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)"; product is Singfiller Cross-linked Sodium Hyaluronate Gel | 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; 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 2026-09-30.
- 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 Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING GEL | Singfiller Cross-linked Sodium Hyaluronate Gel | SINGFILLER ANTI-AGING 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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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: 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 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 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html