DERMATRADE SP Z.O.O · 89-08 · POLAND
For DERMATRADE SP Z.O.O, import alert is 89-08; country is POLAND; 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 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 2026-09-30.
- Firm
- DERMATRADE SP Z.O.O 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
- POLAND verified
- Address
- Prof Mieczyslawa Michal , Bielsko-Biala, POLAND verified
- Date published
- 02/07/2025 verified
- 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 each item verified
- 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 each item verified
What the source says
DERMATRADE SP Z.O.O Date Published : 02/07/2025 Prof Mieczyslawa Michal , Bielsko-Biala, POLAND
— 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 and Product
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:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html