# Medical device manufacturing: class I to IIb, EU MDR | INOPREX

> Non-active medical devices class I, IIa and IIb under EU MDR: nasal sprays, eye drops, oral and throat sprays, wound care, dermatology, gastrointestinal, haemorrhoid products, intimate health, tapes and bandages. Development and legal manufacturing.

Quelle: https://inoporex.de/en/produkte/medizinprodukte/

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## Medical devices: manufactured at INOPREX

INOPREX develops and acts as the legal manufacturer — with responsibility for quality, documentation and market access.

INOPREX is a development and manufacturing partner for medical devices as client projects. EU MDR — Regulation (EU) 2017/745, class I to IIb (non-active) White label uses established, documented formulations from 10,000 units per SKU; private label develops exclusively to briefing. Production runs via qualified contract manufacturers and fillers in the EU.

- **Nasal sprays & nasal rinses** — Nasal spray contract manufacturing: sea water sprays, hypotonic and hypertonic saline solutions and nasal rinses as medical devices with physical mode of action under EU MDR. (https://inoporex.de/en/produkte/medizinprodukte/nasenspray/)
- **Eye drops with hyaluronic acid** — Eye drops as medical devices: hyaluronic acid hydration drops in single-dose (UDV) and multidose containers — development, sterile filling and legal manufacturing via EU partners. (https://inoporex.de/en/produkte/medizinprodukte/augentropfen/)
- **Oral & throat sprays, oral gels** — Oral and throat sprays, oral gels and lozenges with medical purpose under EU MDR — development, claims and legal manufacturing from one source. (https://inoporex.de/en/produkte/medizinprodukte/mund-rachen/)
- **Ear sprays & cerumen removers** — Ear sprays and cerumen removers as medical devices: oily and aqueous solutions as sprays or drops — development, technical documentation and legal manufacturing. (https://inoporex.de/en/produkte/medizinprodukte/ohrensprays/)
- **Wound care: gels, dressings, plasters** — Wound care as medical devices under EU MDR: wound gels, sprays, dressings, plasters, spray plasters, compresses and bandages — development and legal manufacturing. (https://inoporex.de/en/produkte/medizinprodukte/wundversorgung/)
- **Dermatology: warts, nail fungus, barrier creams** — Dermatological medical devices: wart treatments, nail fungus treatments, anti-dandruff products and barrier creams — development, claims and legal manufacturing at INOPREX. (https://inoporex.de/en/produkte/medizinprodukte/dermatologie/)
- **Gastrointestinal: antireflux, fat binder** — Gastrointestinal medical devices: alginate-based antireflux products, chitosan fat binders, satiety and swelling agents and glycerine suppositories — under EU MDR. (https://inoporex.de/en/produkte/medizinprodukte/gastrointestinal/)
- **Haemorrhoid products: ointments, suppositories** — Haemorrhoid products as medical devices: ointments, creams and suppositories — development, technical documentation and legal manufacturing from one source. (https://inoporex.de/en/produkte/medizinprodukte/haemorrhoidal/)
- **Intimate health: vaginal gels, moisturising gels, ovules** — Medical devices for intimate health under EU MDR: vaginal gels, moisturising and hydration gels, ovules and vaginal suppositories — development, technical documentation and legal manufacturing. (https://inoporex.de/en/produkte/medizinprodukte/intimgesundheit/)
- **Tapes, bandages, textile class-I products** — Textile medical devices class I: tapes, bandages, plaster bandages and textile dressings — sourcing, converting and legal manufacturing. (https://inoporex.de/en/produkte/medizinprodukte/tapes-bandagen/)

## Not covered

Not covered: active and electro-medical devices, apparatus, implants, IVDs, software as a medical device.

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 (https://inoporex.de/leistungen/white-label/) uses established, documented formulations (MOQ from 10,000 units per SKU); private label (https://inoporex.de/leistungen/private-label/) develops an exclusive formulation to your briefing (MOQ project-dependent).

## Start a project in this category

Send us your product idea and target market via the contact form — we will come back with the classification, open points and next steps.

Stand: 2026-10-22 · Fachlich verantwortlich: INOPREX Scientific Direction