Reference Source

DERMATRADE SP Z.O.O · 89-08 · POLAND

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
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 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:

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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