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Beskrivning

LandDanmark
ListaSpotlight DK
SektorHälsovård
IndustriLäkemedel & Handel
CS Medica är ett danskt medicintekniskt bolag, dedikerat till läkemedelsforskning, utveckling, tillverkning och global kommersialisering. Bolaget blandar vetenskap och natur för att förbättra patienters liv med cannabinoidterapier för smärtlindring, och för att hantera autoimmuna och stressrelaterade symtom. Globalt erbjuder CS Medica CBD-behandlingar över disk (OTC), inklusive patenterade medicinska produkter, MHRA och MDR-registrerade artiklar, under varumärket CANNASEN® eller med egen märkning.
2023-12-27 13:32:59

The authorization marks a significant step in the company's growth journey, resulting in the U.S. market expansion will be moved forward.

CS MEDICA A/S is proud to announce that they obtained the company registration number: Owner Operator Number: 10089433(Medical Devices) & FEI number: 3030062474(Cosmetic), at the U.S. Food and Drug Administration (FDA) and has registered Eight innovative products for sale in the United States. This milestone approval includes a range of VET and cosmetic products and three medical devices designed for over-the-counter pain relief.

The list of approved products is*;

Medical Devices:
  • Pain Patch
  • Nasal Night Spray
  • Wound Gel
Cosmetic:
  • Anti-Hair loss serum
  • Skin Relief Lotion
Vet products:
  • Pain Patch
  • Pain & Arthritis Gel
  • Wound Gel

Each of these products features Cannabis Sativa L as part of the synergy of the ingredients, reflecting our commitment to harnessing the potentials of cannabis. The [CD1]listing of these products in the FDA database, marks a significant step in our journey, especially considering the U.S. is one of the most developed markets for cannabis-infused products.

The medical devices and cosmetic products will be live on Amazon in January 2024 to advance the company's go-to-market plans for the U.S. territory. New distribution partners are expected to be onboarded during the first quarter of 2024. This strategic move will enable the company to reach a wider audience, ensuring the products are easily accessible to consumers across the United States.

CS MEDICA's CEO, Lone Henriksen, expressed her enthusiasm about this development: "Receiving FDA notification approval for these eight products is not just a triumph for us, but a testament to the research and dedication behind our products. The U.S. market is pivotal in the cannabis sector, but yet a grey market for safety and proof of concept, especially for different functions of the cannabis then traditional ones. Hence, our entry through this approval marks a significant milestone in our global expansion strategy. We are eager to bring our innovative treatments to American consumers and are confident that our presence on the market will be a game-changer in how people experience our products and company.".

For more information about CS MEDICA A/S and our range of treatments, please visit www.cannasen.com.

* https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/textsearch.cfm  - write Cannordic as Company name in the search field.

 [CD1]The FDA only approves drug products. For medical devices (with 510k only) they cleared the device and they give authorization of medical devices class I, by the establishment registration and device listing.