Pharmpur GmbH

Pharmpur GmbH specialises in ophthalmic viscosurgical devices, which are used in eye surgeries. Their portfolio includes silicone oils (like ophthafutur sil 1000 and ophthafutur sil 5000) for retinal procedures, perfluorocarbon liquids (e.g., ophthafutur c2f6) for managing retinal detachment, viscoelastic substances (e.g., AddVisc, Visco 4500) for corneal and cataract surgeries, and gas formulations (e.g., ophthafutur sf6) for intraocular tamponade. They also produce hydroxypropyl methylcellulose-based solutions (e.g., ophthafutur hpmc) for surgical applications.

Pharmpur GmbH is based in Germany, which places its devices under the regulatory framework of the European Union. Since the company’s products are medical devices, they fall under the EU Medical Device Regulations (MDR). The location ensures compliance with EU-wide standards, including mandatory registration in eudamed, the EU’s centralised database for medical devices.

Pharmpur GmbH’s devices are listed in eudamed, the EU’s official database for medical devices. This registry is critical because it ensures transparency, traceability, and compliance with EU Medical Device Regulations. Healthcare providers, regulators, and authorities can verify the legitimacy and classification of these devices through eudamed, which is a requirement under EU law for all medical devices marketed within the region.

Pharmpur GmbH’s devices are classified as Class I, Class IIa, or Class IIb under the EU Medical Device Regulations. This classification determines the level of scrutiny and regulatory requirements they must meet. For example, Class IIb devices (like some silicone oils or perfluorocarbon liquids) undergo stricter risk assessments and clinical evaluations due to their higher potential risk, while Class I devices (e.g., certain viscoelastic solutions) have lower regulatory burdens but still require compliance with basic safety and performance standards.