Mareli Medical AB · 89-08 · SWEDEN
For Mareli Medical AB, import alert is 89-08; country is SWEDEN; 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 Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 P - - 99 Other Cosmetic Raw Materials, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 62 C - - 04 Clonidine Transdermal Patches | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 M - - DD Device, Dermal Replacement | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 02/26/2019; address is Isbergs Gata 18 , Malmo, Skane Lan SWEDEN, verified against its source on 2026-09-30.
- Firm
- Mareli Medical AB 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
- SWEDEN verified
- Address
- Isbergs Gata 18 , Malmo, Skane Lan SWEDEN verified
- Date published
- 02/26/2019 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 P - - 99 Other Cosmetic Raw Materials, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 62 C - - 04 Clonidine Transdermal Patches | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 M - - DD Device, Dermal Replacement | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers each item verified
- FDA notes
- Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . each item verified
What the source says
Mareli Medical AB Date Published : 02/26/2019 Isbergs Gata 18 , Malmo, Skane Lan SWEDEN
— accessdata.fda.gov, retrieved 2026-09-15
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 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 53 P - - 99 Other Cosmetic Raw Materials, N.E.C. Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 62 C - - 04 Clonidine Transdermal Patches Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 79 M - - DD Device, Dermal Replacement Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III . 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 02/26/2019 Desc: Derma Fillers Notes: Class III .
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html