GASTER control® — European MedTech

An abdominal support belt with an integrated extra-parietal compression module

A CE-marked Class I medical device intended for support of the abdominal wall, combining an adjustable textile belt with a manually inflated compression module. Strictly external, adjustable and immediately reversible.

Class I medical device — MDR (EU) 2017/745
Supplied on medical prescription
Patent pending

Support of the abdominal wall

In accordance with its instructions for use (reference LLGC20251201 v.1), GASTER control® is intended for support of the abdominal wall in the following situations. The instructions for use remain the applicable reference document in all circumstances.

Abdominal hypotonia

External mechanical support of the abdominal wall in cases of reduced abdominal wall tone.

Post-operative support

Support of the abdominal wall following surgery, on medical prescription.

Recovery after abdominal surgery

Accompaniment of the recovery phase following abdominal surgery.

Daily physical effort

Limitation of abdominal pressures during everyday physical exertion.

GASTER control® — abdominal support belt with integrated extra-parietal compression module
Use of the compression function

The belt incorporates a localised abdominal compression system by means of an inflatable extra-parietal balloon. This function must be used in strict accordance with the contraindications, precautions and instructions set out in the instructions for use. The device is supplied on medical prescription only.

The Extra-Parietal Balloon (BEP™)

An inflatable pocket integrated into the structure of the belt, positioned outside the body over the epigastric region. Inflation is manual, by means of an integrated hand pump, with no electrical supply and no external energy source. Deflation is immediate via the manual valve.

BEP™ — Patent pending

Strictly external, adjustable, reversible

No component of the device penetrates the body. No anatomical modification is induced. Compression is purely mechanical: it results solely from the increase in volume of the balloon within the belt and its transmission to the facing abdominal area. The device has no pharmacological, immunological or metabolic action, delivers no substance and produces no energy.

Adjustable
Compression level set by the user, adapted to individual morphology and comfort
Non-invasive
Fully external, no contact with internal structures, no pharmacological mechanism
Reversible
Immediately and fully reversible by manual deflation via the valve, or by removing the belt
Woman wearing the GASTER control® abdominal support belt
Man wearing the GASTER control® abdominal support belt
Illustrative photographs

Quality and regulatory framework

GASTER Technology Limited is the legal manufacturer of the device within the meaning of Regulation (EU) 2017/745. CE marking is affixed under the sole responsibility of the legal manufacturer, in accordance with the procedure applicable to Class I devices.

Classification
Class I — Rule 1, Annex VIII, MDR (EU) 2017/745
EMDN code
Y.06.03.99 — Orthosis, spine — others
Legal manufacturer
GASTER Technology Limited — Valletta, Malta
EUDAMED SRN
MT-MF-000047377
Quality management system
ISO 13485:2016
Risk management
EN ISO 14971:2019
Device nature
Non-invasive, non-active, non-sterile, reusable, non-implantable
Traceability
Lot number and UDI on every device
Not an intragastric device

The term "balloon" in the device name refers exclusively to the external inflatable pocket used as a mechanical compression element. The device is not implantable, not invasive within the meaning of Annex VIII of Regulation (EU) 2017/745, and is not an endoscopic or intragastric device. It is not comparable to a gastric balloon.

Regulatory information, contraindications and safe use

About GASTER Technology

GASTER Technology Limited is a Malta-based European medical device company. We design and manufacture external mechanical support solutions for the abdominal wall, and we license the BEP™ compression module to manufacturers of medical textiles and orthotic devices.

Established in Valletta, Malta Corporate registration C 84832 — EU jurisdiction
CE-marked under MDR (EU) 2017/745 Class I medical device — EUDAMED SRN MT-MF-000047377
Manufacturing under ISO 13485:2016 Documented supplier qualification and full product traceability
Learn more about our company

How can we work together?

GASTER control® is open to collaboration across clinical, commercial and industrial environments.

Healthcare professional

Product information, intended purpose, contraindications, fitting guidance and prescribing details.

Access professional information
Distribution partner

Distribution agreements, licensing, and market-specific regulatory adaptation.

Explore partnership models
OEM integration

Integrate the BEP™ compression module into your own medical textiles or orthotic devices.

Discuss integration

GASTER control® is a Class I medical device intended for support of the abdominal wall. The instructions for use, reference LLGC20251201 v.1, remain the applicable reference document in all circumstances and must be read before any use. The device is supplied on medical prescription and is not reimbursed.