Products · Medical devices
Oral, throat and mouth sprays and oral gels
Sprays, gels and lozenge formats for the oral cavity and pharynx — developed and documented as medical devices.
INOPREX is a development and manufacturing partner for oral, throat and mouth sprays, oral gels and lozenge formats with a medical purpose. Application targets the oral cavity and pharynx; the typical classification under EU MDR is class IIa where the effect remains local on the mucosa without systemic absorption.
Product portfolio
- Oral and throat sprays
- Oral gels
- Lozenges with physical mode of action
- Oral rinses with medical purpose
- Soothing sprays based on plant extracts
Regulatory classification
EU MDR — Regulation (EU) 2017/745, rule 21 (application in the oral cavity up to the pharynx): class IIa. Systemic absorption would change the class — assessed and justified per product.
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
Where is the boundary to lozenges as food?
At the intended purpose: a medical purpose (e.g. local wetting, soothing irritation in the pharynx) makes the product a medical device; mere refreshment or taste is a food or supplement. We document the distinction upfront.
Are claims like “soothing” permitted?
Only if substantiated specifically for the product and correctly classified. We review every claim upfront and record the evidence in the technical documentation.
Which dosage forms are possible?
Spray bottles, dosing pumps, jars, tubes and lozenge formats — with compatibility testing per product.
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.