Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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