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INPOINT MEDICARE

Romania RO-MF-000022427 Last updated 21 Oct 2026

Devices
39
Registries
EUDAMED
FDA recalls
0

Catalogue39

About

InPoint Medicare is the manufacturer of the InPoint DUO brand - rolls and sterilization bags with class 5 integrator indicators integrated into the packaging according to EN ISO 11140-1. Products manufactured in Romania, tested by the ISEGA Institute (Germany), with EU-wide design.

Translated from the manufacturer's own website. Source

What INPOINT MEDICARE makes

The company manufactures sterilization reels and self-seal sterilization pouches, all incorporating internal and external process indicators for steam or ethylene oxide sterilization. The reels are available in gusseted or non-gusseted designs, with varying dimensions such as 75mm×200m or 500mm×100m, while pouches come in sizes like 75mm×200mm up to 400mm×600mm. The INPOINT DUO brand includes dual-format packaging solutions with integrated Class 5 integrator indicators, compliant with EN ISO 11140-1 standards.

These products fall under EU Device Class I and are listed in the euDaMed database. The manufacturer operates from Romania, adhering to EU regulatory requirements for sterilization packaging.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does InPoint Medicare manufacture?

InPoint Medicare specializes in sterilization packaging solutions, specifically sterilization reels and self-seal sterilization pouches. The reels come in both gusseted and non-gusseted designs, with dimensions ranging from 75mm×200m to 500mm×100m, while the pouches vary in size from 75mm×200mm up to 400mm×600mm. All products incorporate internal and external process indicators for steam or ethylene oxide sterilization, ensuring visibility of the sterilization process.

Where is InPoint Medicare based, and where are their devices manufactured?

InPoint Medicare is based in Romania, where all its devices are manufactured. The company adheres to EU regulatory standards, ensuring compliance with European medical device requirements throughout production.

Which regulatory databases list InPoint Medicare’s devices?

InPoint Medicare’s devices are listed in the euDaMed database, which is the official EU registry for medical devices. This listing confirms their presence in the European market under the applicable regulatory framework.

How are InPoint Medicare’s sterilization packaging devices classified under EU regulations?

InPoint Medicare’s sterilization reels and pouches fall under EU Device Class I, the lowest risk category for medical devices. This classification applies because these products are primarily used for packaging and sterilization monitoring rather than direct patient treatment or invasive procedures.

What distinguishes the INPOINT DUO brand from other sterilization packaging solutions?

The INPOINT DUO brand features dual-format sterilization packaging—combining reels and pouches—with integrated Class 5 integrator indicators compliant with EN ISO 11140-1. These indicators provide reliable visual confirmation of successful sterilization (steam or ethylene oxide), ensuring both internal and external process validation for enhanced traceability and safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Romania(from SRN)
Address
57, GURA LEULUI , CHIAJNA , Romania
Phone
+40743145407
PRRC contact
DRAGOS CINDEA
EUDAMED SRN
RO-MF-000022427