# DERMATRADE SP Z.O.O · 89-08 · POLAND — FDA import alert red lists: firms subject to detention without physical examination

For DERMATRADE SP Z.O.O · 89-08 · POLAND, 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 POLAND; product is All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products; product code is 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 P - - KY Implant, dermal, for aesthetic use in the hands; date published is 02/07/2025; address is Prof Mieczyslawa Michal , Bielsko-Biala, POLAND, verified against its source on 2026-09-16.

- **Firm:** DERMATRADE SP Z.O.O _(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:** POLAND _(verified: appears in the quote below)_
- **Address:** Prof Mieczyslawa Michal , Bielsko-Biala, POLAND _(verified: appears in the quote below)_
- **Date published:** 02/07/2025 _(verified: appears in the quote below)_
- **Product code:** 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 P - - KY Implant, dermal, for aesthetic use in the hands _(verified: each item appears in the quote below)_
- **Product:** All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products | All dermal filler and injectable hyaluronic acid products _(verified: each item appears in the quote below)_

## What the source says

> DERMATRADE SP Z.O.O Date Published : 02/07/2025 Prof Mieczyslawa Michal , Bielsko-Biala, POLAND 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) Date Published: 02/07/2025 Desc: All dermal filler and injectable hyaluronic acid products Notes: 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 02/07/2025 Desc: All dermal filler and injectable hyaluronic acid products Notes: 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/07/2025 Desc: All dermal filler and injectable hyaluronic acid products Notes: 79 P - - KY Implant, dermal, for aesthetic use in the hands Date Published: 02/07/2025 Desc: All dermal filler and injectable hyaluronic acid products Notes:

## 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/).