Products · Medical devices
Ear sprays & cerumen removers
Oily and aqueous ear sprays and cerumen removers — developed and legally manufactured as medical devices.
INOPREX is a development and manufacturing partner for ear sprays and cerumen removers. The products moisten the ear canal and support the mechanical removal of earwax — a physical mode of action, not pharmacological. Classification follows EU MDR per product, typically class I to IIa.
Product portfolio
- Oily ear sprays
- Aqueous ear sprays
- Oil-based cerumen removers
- Sea water sprays
- Ear drops
Regulatory classification
EU MDR — Regulation (EU) 2017/745. Cerumen removers and ear sprays: class I to IIa per product; sprays with longer application duration are assessed individually.
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
Are cerumen removers medical devices or cosmetics?
Cerumen removers with a medical purpose (softening and dissolving earwax) are medical devices. Purely cosmetic outer-ear cleaners fall under the cosmetics regulation — we clarify the classification in the project.
Which fill volumes are common?
Small volumes between 10 and 50 ml, depending on the spray or dropper applicator.
What is the MOQ?
White label from 10,000 units per SKU; special formulations 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.