Products · Medical devices
Gastrointestinal medical devices: antireflux & more
Alginate-based antireflux products, chitosan fat binders, swelling agents and glycerine suppositories — as medical devices.
INOPREX is a development and manufacturing partner for gastrointestinal medical devices: alginate-based antireflux products, chitosan fat binders, satiety and swelling agents, and glycerine suppositories. The mode of action is physical — alginates form a mechanical barrier, swelling agents work via volume, glycerine osmotically and locally. Classification under EU MDR is per product and use.
Product portfolio
- Alginate antireflux suspensions
- Chitosan fat binders
- Satiety and swelling agents
- Glycerine suppositories
- Combination formats
Regulatory classification
EU MDR — Regulation (EU) 2017/745. Oral application from the pharynx to the stomach: class IIa/IIb per product; rectal use: class IIb — assessed and justified per application.
INOPREX develops, manufactures and takes on regulatory responsibility — in the role that fits your project. For medical devices we act as the legal manufacturer under EU MDR. For cosmetics and food supplements we either take on the role of the responsible person or the person placing the product on the market, or we manage development and production while your brand remains the market operator. Production runs together with leading contract manufacturers and fillers in the EU. White label uses established, documented formulations (MOQ from 10,000 units per SKU); private label develops an exclusive formulation to your briefing (MOQ project-dependent).
Frequently asked questions
Why are alginates medical devices?
Because they act mechanically: after swallowing they form a floating barrier/foam layer in the stomach. No pharmacological, immunological or metabolic action — hence the EU MDR applies, not medicines law.
What has to be considered for claims?
The line to disease-related statements is narrow. We formulate product-specific, substantiated claims and keep the justification in the technical documentation.
What MOQ applies?
White label from 10,000 units per SKU; private label project-dependent.
Request your project
Send us your product idea, dosage form and target market via the contact form — we will respond within two working days with an initial assessment.