# Mareli Medical AB · 89-08 · SWEDEN — FDA import alert red lists: firms subject to detention without physical examination

For Mareli Medical AB · 89-08 · SWEDEN, 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 SWEDEN; 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 2026-09-16.

- **Firm:** Mareli Medical AB _(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:** SWEDEN _(verified: appears in the quote below)_
- **Address:** Isbergs Gata 18 , Malmo, Skane Lan SWEDEN _(verified: appears in the quote below)_
- **Date published:** 02/26/2019 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers | Derma Fillers _(verified: each item appears in the quote below)_
- **FDA notes:** Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . | Class III . _(verified: each item appears in the quote below)_

## What the source says

> Mareli Medical AB Date Published : 02/26/2019 Isbergs Gata 18 , Malmo, Skane Lan SWEDEN 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 .

## 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/).