About GASTER Technology — A European MedTech Company | GASTER control
About GASTER Technology — A European MedTech Company
GASTER Technology Limited is a Malta-based medical device company. We develop external mechanical support solutions for the abdominal wall, and license the BEP™ compression module to manufacturers of medical textiles and orthotic devices.
Who we are
GASTER Technology Limited is a medical device company incorporated under Maltese law, with operations spanning Malta, France and other European markets. Our engineering work focuses on a single, well-defined object: controlled, adjustable and reversible external compression of the abdominal wall.
The company develops, manufactures through a qualified supply chain, and places on the market GASTER control®, a Class I medical device under Regulation (EU) 2017/745 intended for support of the abdominal wall. The device is supplied on medical prescription and used under healthcare professional supervision, in accordance with its instructions for use.
Beyond the finished device, our core asset is a component: the BEP™ extra-parietal compression module, designed from the outset as a self-contained sub-assembly that can be integrated into host garments and orthotic devices manufactured by third parties. This licensing model allows partners to retain their own brand, their own distribution channels and their responsibilities as legal manufacturer.
From Malta to European deployment
GASTER Technology Limited was established in Valletta, Malta, a jurisdiction chosen for its position at the crossroads of European MedTech innovation and the Mediterranean industrial landscape. Malta provides an English-speaking corporate environment within the European Union, with full regulatory alignment to the EU medical device framework and access to the EUDAMED database for device traceability.
From this Maltese foundation, our first commercial deployment took place in France, through an exclusive national distribution partner, with supply by orthotic specialists and pharmacists on medical prescription. France was selected as the launch market for its dense and structured network of orthotic supply professionals and its established regulatory framework for orthotic-class medical devices.
Our trajectory now extends across Europe. Commercial development is underway in additional European markets, with a structured rollout planned for the United Kingdom and the DACH region (Germany, Austria, Switzerland) in 2027, alongside ongoing exploration of OEM partnerships with European medical device manufacturers and medical textile producers.
CE marking obtained
Conformity under Regulation (EU) 2017/745, Class I, December 2025.
First European deployment
Placing on the market in France through an exclusive distribution partner.
UK & DACH expansion
United Kingdom, Germany, Austria, Switzerland. First OEM partnerships.
What we do
Our activity is structured around three interconnected pillars.
The device — GASTER control®
GASTER control® is an abdominal support belt incorporating an inflatable extra-parietal compression module, designed to apply controlled, adjustable and reproducible mechanical compression over the epigastric region. It is a Class I medical device under Regulation (EU) 2017/745 (EMDN code Y.06.03.99), available in three sizes, intended for support of the abdominal wall and used within medical care pathways under healthcare professional supervision.
The technology — the BEP™ module
The Extra-Parietal Balloon is a complete compression sub-assembly: inflatable structure, semi-rigid compressive shield with segmented reinforcement blades, manual inflation system and deflation valve. Its architecture, textile engineering and associated mechanical principles are proprietary, and are the subject of a patent filed in France with a strategy designed to support international extensions.
Quality and regulatory framework
The company operates a quality management system based on ISO 13485:2016, with risk management established in accordance with EN ISO 14971:2019. Manufacturing is entrusted to an ISO 13485:2016-certified partner, following a documented supplier qualification process. Every device carries a lot number and a Unique Device Identifier, ensuring full product traceability. A post-market surveillance system is in place in accordance with Article 83 of the Regulation.
Key figures
Leadership
The company is led by Alexandra Vorbauer, Chief Executive Officer and Director of Publication, overseeing corporate strategy, regulatory affairs and industrial partnerships. Day-to-day operations are conducted in coordination with the manufacturing partners and the commercial network.
Regulatory compliance of the device is the responsibility of the legal manufacturer, which maintains the technical documentation, the risk management file and the post-market surveillance system required by Regulation (EU) 2017/745.
Corporate identity
GASTER Technology Limited
- Legal form
- Private limited company (Ltd) — Maltese law
- Registered office
- 5/1 Merchants Street
Valletta VLT 1171
Malta — European Union - Trade register
-
C 84832(Malta Business Registry) - EUDAMED SRN
MT-MF-000047377- Regulatory framework
- Regulation (EU) 2017/745 — Class I medical device
- Classification rule
- Rule 1, Annex VIII — non-invasive device
- EMDN code
- Y.06.03.99 — Orthosis, spine — others
- Quality system
- ISO 13485:2016
- Manufacturing
- ISO 13485:2016 certified supply chain
- Risk management
- EN ISO 14971:2019 applied
- Manufacturer reference
-
GSTR_LIPOLINE01— 3 sizes - Basic UDI-DI
37700382GSTR_LIPOLINE01SG- Instructions for use
-
LLGC20251201 v.1(CE marking 1 December 2025) - Reimbursement status
- Not listed on the LPPR — not reimbursed
- CEO & Director of Publication
- Alexandra Vorbauer
Get in touch
For commercial enquiries, distribution partnerships, OEM integration, regulatory questions or press requests.
Contact details Legal noticeAlways refer to the instructions for use, reference LLGC20251201 v.1, supplied with the device, which remains the applicable reference document in all circumstances.
For institutional inquiries, please refer to our Legal Notice and Contact Details.