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Curaleaf International, in Partnership with Jupiter Research, Secures EU Medical Device Certification for Europe's First Handheld Liquid Inhalation Device

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Curaleaf International and Jupiter Research (TLLTF) have secured EU medical device certification for Europe's first handheld liquid inhalation device designed for medical cannabis administration. The device, certified as a Class IIa medical device under EU Regulation 2017/745, features a magnetic snap-in cartridge and rechargeable power supply for consistent cannabinoid delivery.

The certification enables commercialization across multiple global markets, including European countries, the UK, Canada, and Australasia. The device's technical file and EU Declaration of Conformity were approved by an EU Notified Body, validating its quality, safety, and clinical effectiveness.

Curaleaf International e Jupiter Research (TLLTF) hanno ottenuto la certificazione UE per dispositivi medici per il primo dispositivo portatile a inalazione liquida in Europa, progettato per la somministrazione di cannabis medica. Il dispositivo, certificato come dispositivo medico di Classe IIa secondo il Regolamento UE 2017/745, è dotato di una cartuccia a innesto magnetico e di un'alimentazione ricaricabile per garantire una somministrazione costante di cannabinoidi.

Questa certificazione permette la commercializzazione in diversi mercati globali, inclusi paesi europei, Regno Unito, Canada e Australasia. Il fascicolo tecnico del dispositivo e la Dichiarazione di Conformità UE sono stati approvati da un organismo notificato UE, confermando la qualità, la sicurezza e l'efficacia clinica del prodotto.

Curaleaf International y Jupiter Research (TLLTF) han obtenido la certificación de dispositivos médicos de la UE para el primer dispositivo portátil de inhalación líquida en Europa diseñado para la administración de cannabis medicinal. El dispositivo, certificado como dispositivo médico Clase IIa bajo el Reglamento de la UE 2017/745, cuenta con un cartucho magnético de encaje y una fuente de alimentación recargable para una entrega constante de cannabinoides.

La certificación permite la comercialización en múltiples mercados globales, incluyendo países europeos, Reino Unido, Canadá y Australasia. El expediente técnico del dispositivo y la Declaración de Conformidad de la UE fueron aprobados por un Organismo Notificado de la UE, validando su calidad, seguridad y eficacia clínica.

Curaleaf InternationalJupiter Research(TLLTF)는 의료용 대마초 투여를 위해 설계된 유럽 최초의 휴대용 액상 흡입기기에 대해 EU 의료기기 인증을 획득했습니다. 이 장치는 EU 규정 2017/745에 따른 Class IIa 의료기기로 인증받았으며, 자기식 카트리지와 재충전 가능한 전원 공급 장치를 갖추어 일관된 칸나비노이드 전달을 보장합니다.

이 인증은 유럽 국가들, 영국, 캐나다, 오스트랄라시아 등 여러 글로벌 시장에서의 상업화를 가능하게 합니다. 장치의 기술 문서와 EU 적합성 선언서는 EU 공인 기관에 의해 승인되어 품질, 안전성 및 임상 효과가 검증되었습니다.

Curaleaf International et Jupiter Research (TLLTF) ont obtenu la certification européenne pour dispositifs médicaux du premier dispositif portable d'inhalation liquide en Europe, conçu pour l'administration de cannabis médical. L'appareil, certifié comme dispositif médical de classe IIa selon le règlement européen 2017/745, est équipé d'une cartouche à encliquetage magnétique et d'une alimentation rechargeable pour une délivrance constante de cannabinoïdes.

Cette certification permet la commercialisation sur plusieurs marchés mondiaux, notamment en Europe, au Royaume-Uni, au Canada et en Australasie. Le dossier technique de l'appareil ainsi que la déclaration de conformité UE ont été approuvés par un organisme notifié de l'UE, validant ainsi sa qualité, sa sécurité et son efficacité clinique.

Curaleaf International und Jupiter Research (TLLTF) haben die EU-Zertifizierung für medizinische Geräte für Europas erstes tragbares Flüssiginhalationsgerät zur Verabreichung von medizinischem Cannabis erhalten. Das Gerät, zertifiziert als Medizinprodukt der Klasse IIa gemäß EU-Verordnung 2017/745, verfügt über eine magnetische Steckkartusche und eine wiederaufladbare Stromversorgung für eine gleichbleibende Cannabinoidabgabe.

Die Zertifizierung ermöglicht die Vermarktung in mehreren globalen Märkten, darunter europäische Länder, das Vereinigte Königreich, Kanada und Australasien. Die technische Dokumentation des Geräts und die EU-Konformitätserklärung wurden von einer EU-benannten Stelle genehmigt, was die Qualität, Sicherheit und klinische Wirksamkeit bestätigt.

Positive
  • First EU-certified handheld liquid inhalation device for medical cannabis in Europe
  • Certification enables market access across multiple global regions including Europe, UK, Canada, and Australasia
  • Partnership between Curaleaf and Jupiter Research strengthens market position
  • Device meets highest regulatory standards for medical devices in Europe
Negative
  • None.

LONDON, May 12, 2025 /PRNewswire/ -- Curaleaf International, part of Curaleaf Holdings, Inc. (TSX: CURA) in collaboration with Jupiter Research LLC, a subsidiary of TILT Holdings Inc. ("TILT") (Cboe CA: TILT) (OTCPK: TLLTF), has secured regulatory approval for the first handheld liquid inhalation device designed for precise medical cannabis administration. This EU medical device certification (Regulation (EU) 2017/745) paves the way for improved patient options and a new era of innovation in medical cannabis delivery.

The liquid inhalation device is now certified as a Class IIa medical device, meeting rigorous European regulatory standards. The device includes a magnetic snap-in cartridge and a rechargeable power supply, engineered to provide a consistent and controlled cannabinoid delivery. A comprehensive technical file and full EU Declaration of Conformity were assessed and approved by a recognised EU Notified Body, validating the device's quality, safety, and clinical robustness.

EU certification supports deployment in multiple global markets and once commercialised, will enable healthcare professionals to recommend the device offered by Curaleaf International in countries including European countries, the UK, Canada, and regions across Australasia.

Boris Jordan, Chairman and CEO of Curaleaf, commented on this achievement:
"Achieving EU medical certification is more than a regulatory milestone—it's a signal that medical cannabis innovation is moving into the mainstream of global healthcare. We're proud to offer a device that meets the highest standards of safety and quality, and we look forward to supporting patients and healthcare providers across Europe and beyond with a new, accurate and discrete option for treatment."

Echoing this sentiment, TILT's Chief Executive Officer Tim Conder, added:
"Partnering with Curaleaf International on this project has been a natural extension of our long-standing partnership in the US. By delivering industry-leading, user-friendly solutions, our collaboration exemplifies how technology can revolutionise healthcare. Achieving EU medical certification on IP developed by our subsidiary Jupiter Research, validates the robustness of our engineering and R&D functions and sets a new benchmark for the industry."

This development reinforces Curaleaf International's role at the forefront of advancing access to legal, high-quality cannabis treatments across Europe and other international markets.

About Curaleaf International
Curaleaf International is shaping the future of cannabis through its commitment to research and product excellence. Powered by a strong presence at all stages of the supply chain, its unique distribution network throughout Europe, Canada and Australasia brings together pioneering research with cutting-edge cultivation, extraction, and production. Amidst a rapid growth trajectory, the emphasis on quality and expertise aims to ensure the delivery of safe and legal cannabis.

Curaleaf International's network includes a clinic, pharmacy, and laboratory in the UK; cultivation and EU-GMP processing facilities in Portugal; an EU-GMP processing, quality assurance and research site in Spain; Four20 Pharma wholesaler and distributor in Germany; a Polish wholesaler and clinic; and the EU-GMP producer Northern Green Canada.

Curaleaf International is part of Curaleaf Holdings, Inc., a leading international producer and distributor of consumer cannabis products.

About TILT and Jupiter Research
TILT Holdings manages a diverse portfolio of companies in the cannabis industry, encompassing technology, hardware, cultivation, and production. Its core business, Jupiter Research LLC, is a wholly owned subsidiary and a global distribution leader in the vaporization segment. Jupiter is dedicated to hardware design, research, development, and distribution to support cannabis brands and retailers across the United States, Canada, South America, and the European Union. Additionally, TILT is a multi-state operator, with cultivation and production facilities in three states under the Commonwealth Alternative Care and Standard Farms brands. For more information, visit www.tiltholdings.com.

Media Contact:

Curaleaf International:
Beth Sweet-Escott
Head of Communications, Curaleaf International
media@curaleafint.com 

TILT:
Lynn Ricci
VP of Investor Relations & Corporate Communications, TILT Holdings Inc.
lricci@tiltholdings.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/curaleaf-international-in-partnership-with-jupiter-research-secures-eu-medical-device-certification-for-europes-first-handheld-liquid-inhalation-device-302451697.html

SOURCE Curaleaf International

FAQ

What certification did TLLTF receive for its medical cannabis device in Europe?

TLLTF's Jupiter Research, in partnership with Curaleaf International, received EU medical device certification (Regulation EU 2017/745) for their handheld liquid inhalation device, classified as a Class IIa medical device.

What markets can TLLTF's new medical cannabis device be sold in?

The EU-certified device can be commercialized in European countries, the UK, Canada, and regions across Australasia.

What are the key features of TLLTF's new medical cannabis inhalation device?

The device features a magnetic snap-in cartridge and rechargeable power supply, designed to provide consistent and controlled cannabinoid delivery.

Who partnered with TLLTF to develop the EU-certified medical cannabis device?

Jupiter Research (TLLTF) partnered with Curaleaf International, a part of Curaleaf Holdings, to develop and certify the medical cannabis inhalation device.
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