nir-vana innovation network

The Austrian medical technology company in Graz has been developing and selling various types of medical products for 40 years, supplying it to a broad variety of healthcare facilities. Since the COVID-19 pandemic, the company's customers include the Austrian Federal Government and the German Federal Ministry of Health to which they deliver up to 16 million COVID-19 antigen rapid tests (professional use) per week.

In addition, the company recently won, together with four other European suppliers, a European Commissions framework agreement contract for the delivery of a high number of COVID-19 rapid tests to various EU countries.

In March 2021, the CE marking for self-application of the COVID-19 anterior nasal tests (private use) had been approved officially. With this CE marking from TÜV SÜD the company documents conformity with the applicable EU directives and thus creates the opportunity for its products to be marketed and distributed throughout the EU. This CE mark signals that the company guarantees the quality and safety of its products to its customers and is also liable for them.

As the company has already very good contacts to national agencies and large distributors of consumer products and drugstores in Germany, the client is now seeking similar distribution partners for their COVID-19 test kits (professional and private use) in UK, Spain, France, Italy and Switzerland.

Package content (single packaging):
- 1 test cassette
- 1 anterior nasal swab (fine plastic brush)
- 1 vial with extraction solution
- 1 tube with dropper cap
- 1 user manual (for private use)

Delivery quantities:
20 million pieces of COVID-19 antigen tests for private use are available per week.

Unit variants (Stockkeeping Units (SKU)):
Single packaging: 50 pack of 1 piece / in 1 box = 9,000 pieces / pallet
or 20 pieces: 50 pack of 20 pieces / 1,000 pieces in 1 box = 20,000 pieces / pallet
In total, the company has three warehouses in order to be able to temporarily store the products made in China.

Advantages & innovations

The efficiency of the privately used COVID-19 tests has been approved by four different studies with 99.1 percent validity in comparison to professionally used COVID-19 test kits. The COVID-19 test kid for private use is CE0123 certified by TÜF SÜD Product Service GmbH in Munich, which means that 100% of the European Commission’s product guidelines for medical items have been fulfilled. Additionally, the company is EN ISO 13485, ISO 13485:2016 certified, which proves a quality management system for the design and manufacture of medical devices. The product is listed and validated by the Paul-Ehrlich-Institut for delivery to the German market. The product is tested and already on the market.

Stage of development

Already on the market

Partner sought

The company is looking for partners in the medical field, who dispose of many years of experience and are looking for new medical items to sell. Preferred partners do already have national sales networks and distribution channels as well as good knowledge of national tender procedures within the medical sector. Typical partners may be drugstore chains, pharmacies, medical distributors, clinics, health institutions, hospitals, etc.