Partners & Integrations

Partners & Integrations

Bring GASTER control® technology to your market

A CE-marked Class I abdominal support device with an integrated extra-parietal compression module — available through distribution partnerships, licensing agreements or OEM integration.

A regulated device with an operational distribution model

GASTER control® is not a concept. It is a CE-marked Class I medical device with declared conformity under Regulation (EU) 2017/745, manufactured under an ISO 13485:2016 quality management system, and supplied on medical prescription through an established distribution channel in France.

The device combines a textile abdominal support belt with an integrated extra-parietal compression module — the BEP™ platform — inflated manually via a built-in hand pump. The module is a self-contained sub-assembly, designed from the outset to be integrated into host garments and orthotic devices manufactured by third parties.

Our partnership model is built around a component technology: the BEP™ compression module is licensed to host manufacturers, who retain their own brand, their own distribution channels and their responsibilities as legal manufacturer of the finished device.

France: proof of model, proof of scalability

France is the reference and pilot market for GASTER control®, demonstrating the full commercial and regulatory model within an operational healthcare environment.

Distribution model

Exclusive national distribution through a single partner. The device is supplied by orthotic specialists and pharmacists, strictly on medical prescription.

Structured training materials are provided to prescribing physicians and to the professionals who supply and fit the device. A dedicated guide supports the first fitting of the patient, alongside the instructions for use, which remain the applicable reference document in all circumstances.

Prescription only Orthotic fitting Pharmacy channel
3 sizes
Covering a waist circumference of 75 to 145 cm
Class I
Rule 1, Annex VIII, MDR (EU) 2017/745
CE marked
EUDAMED SRN MT-MF-000047377
ISO 13485
Certified manufacturing, full lot and UDI traceability

Flexible partnership structures, adapted to your context

GASTER control® is open to non-dilutive strategic partnerships and long-term industrial collaboration. The company is not seeking equity investment at this stage.

Exclusive distribution

National or regional exclusivity for qualified distribution partners with orthotic, pharmacy or medical device networks. Regulatory support and training included.

Licensing agreement

Licensing of the BEP™ technology and associated intellectual property for integration into your own product portfolio, under your own brand, with technical support from GASTER Technology.

OEM integration

Integration of the BEP™ compression module into your wearable medical devices, abdominal support systems or medical textiles.

Learn more about OEM integration options

Built for integration, not just for distribution

The BEP™ module was designed as a component rather than as a finished consumer product. This is what makes it transposable: a host manufacturer integrates the compression module into an existing garment or orthotic device, and markets it under its own brand within its own regulatory framework.

Self-contained compression sub-assembly, ready for integration into existing product lines
The host manufacturer retains its brand, its channels and its role as legal manufacturer
Applicable to abdominal support belts, post-operative garments and medical textiles
No electrical supply, no embedded energy source, no integrated medicinal substance
Scalable manufacturing model with ISO 13485-certified production

Regulatory capabilities

MDR Class I CE marking support Controlled terminology framework Customs and shipping documentation Market-specific regulatory adaptation International IP strategy

What a partner takes on, and what we provide

Under Regulation (EU) 2017/745, the party placing a finished device on the market under its own name assumes the responsibilities of legal manufacturer: technical documentation, conformity assessment, CE marking, risk management, instructions for use and post-market surveillance. Our role is to supply the compression module, the associated technical documentation and the engineering support required for integration.

Any claim relating to a finished device incorporating the BEP™ module falls within the responsibility of its legal manufacturer, and must correspond to the intended purpose declared for that device and to the evidence supporting it.
Regulatory information and safe use

Building an ecosystem around external abdominal compression

Medical device manufacturers

Integration of the BEP™ module into existing abdominal support or post-operative devices. Co-development of new product lines.

Healthcare distributors

Orthotic networks, pharmacy chains and specialised medical distributors operating prescription-based models.

Textile and garment manufacturers

Producers of medical textiles and compression garments seeking to add an adjustable compression function to their existing ranges.

Ready to explore a partnership?

Whether you are a distributor, a manufacturer or a clinical institution, our team is available to discuss collaboration models suited to your market.

Contact the partnerships team
GASTER control® is a CE-marked Class I medical device intended for support of the abdominal wall. Supplied on medical prescription. The instructions for use, reference LLGC20251201 v.1, remain the applicable reference document in all circumstances. Partnership enquiries are confidential and subject to mutual evaluation. Patent pending.
GASTER control® — GASTER Technology Limited, 5/1 Merchants Street, Valletta VLT 1171, Malta.