Reference Source

AMDERMIK SL · 66-41 · SPAIN

For AMDERMIK SL, import alert is 66-41; country is SPAIN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is H-100 Bio-Revitalisation | World Dermic PeptiDermic | World Dermic MesoHair | World Dermic MesoLipo | World Dermic Ampelopsin | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic PeptiDermic | World Dermic MesoHair | World Dermic MesoLipo | World Dermic Ampelopsin | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | H-50 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoLipo | World Dermic MesoHair | World Dermic PeptiDermic; 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 listed twice: 04/24/2024 and 03/09/2017; address is listed twice: Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN and Avinguda Cabrera 36 , Mataro, Barcelona SPAIN, verified against its source on 2026-10-01.

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
Avinguda Cabrera 36 , Mataro, Barcelona SPAIN also listed
Date published
04/24/2024 verified
03/09/2017 also listed
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
H-100 Bio-Revitalisation | World Dermic PeptiDermic | World Dermic MesoHair | World Dermic MesoLipo | World Dermic Ampelopsin | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic PeptiDermic | World Dermic MesoHair | World Dermic MesoLipo | World Dermic Ampelopsin | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | H-50 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoLipo | World Dermic MesoHair | World Dermic PeptiDermic 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

— accessdata.fda.gov, retrieved 2026-09-24

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 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 PeptiDermic 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic MesoHair 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 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 - - 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 PeptiDermic 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 MesoLipo 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: 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: H-50 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 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: World Dermic PeptiDermic

— all from accessdata.fda.gov, retrieved 2026-09-24

The same source also states

Amdermik Sl Date Published : 03/09/2017 Avinguda Cabrera 36 , Mataro, Barcelona SPAIN

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

Product code

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.'

Source

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