Reference Source

AMDERMIK SL · 66-41 · SPAIN

For AMDERMIK SL · 66-41 · SPAIN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SPAIN; product is World Dermic MesoLipo | World Dermic PeptiDermic | H-100 Bio-Revitalisation | World Dermic Ampelopsin | H-50 Bio-Revitalisation | World Dermic MesoHair | World Dermic MesoLipo | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoHair | World Dermic PeptiDermic | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic PeptiDermic | World Dermic MesoLipo | World Dermic MesoHair | H-50 Bio-Revitalisation; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/24/2024; address is Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN, verified against its source on 2026-09-16.

Firm
AMDERMIK SL verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
SPAIN verified
Address
Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN verified
Date published
04/24/2024 verified
Product code
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
World Dermic MesoLipo | World Dermic PeptiDermic | H-100 Bio-Revitalisation | World Dermic Ampelopsin | H-50 Bio-Revitalisation | World Dermic MesoHair | World Dermic MesoLipo | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoHair | World Dermic PeptiDermic | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic PeptiDermic | World Dermic MesoLipo | World Dermic MesoHair | H-50 Bio-Revitalisation each item verified
FDA notes
The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' | The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' also on this page
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

AMDERMIK SL Date Published : 04/24/2024 Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic MesoLipo 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic MesoHair 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic MesoLipo 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic MesoHair 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic MesoLipo 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic MesoHair 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation

— accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Amdermik Sl Date Published : 03/09/2017 Avinguda Cabrera 36 , Mataro, Barcelona SPAIN 53 L - - -- Skin Care Prep Date Published: 03/09/2017 Desc: Hyaluronidase Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/09/2017 Desc: Hyaluronidase Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.'

— 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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