Products · Medical devices
Nasal sprays & nasal rinses with a physical mode of action
Sea water, hypertonic and hypotonic solutions — documented and filled as medical devices.
INOPREX is a development and manufacturing partner for nasal sprays and nasal rinses with a physical mode of action: sea water sprays, isotonic, hypotonic and hypertonic saline solutions and nasal rinsing devices. The mode of action is physical (moisturising, rinsing, mechanical cleansing), not pharmacological — hence the classification as medical devices under EU MDR, typically class IIa.
Product portfolio
- Sea water nasal sprays (isotonic)
- Hypertonic saline solutions
- Hypotonic saline solutions
- Nasal rinses and irrigation solutions
- Moisturising nasal sprays
- Sea salt sticks and sachets
Regulatory classification
EU MDR — Regulation (EU) 2017/745, rule 21 (application in the nasal cavity): class IIa. Combinations with antimicrobial additives or dosing pumps are assessed 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
Why is a sea water nasal spray a medical device?
Because its intended purpose is medical: moisturising the nasal mucosa and supporting physiological function through mechanical cleansing. The mode of action is physical; pharmacologically active sprays would be medicinal products and are outside our scope.
Which containers are possible?
Pump dispensers, metered-dose sprays, dropper bottles and single-dose sachets. Material compatibility and shelf life are checked within the project.
Are the sprays also available for children?
Yes — age-appropriate formats and concentrations are part of development; usage limits are documented in the labelling.
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.