Skip to content

Diagnostica AS

Norway NO-MF-000041375 Last updated 21 Oct 2026 Part of Diagnostica, Inc.

Is this your brand? Sign in to claim this brand

Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

  • Spirare Web Ref Spirare Web SPDWB0

    Class IIa EUDAMED Active

  • Spirare PC Ref Spirare PC SPDSW0

    Class IIa EUDAMED Active

About

Spirare offers spirometry, ECG and 24-hour blood pressure in one PC-based system. Developed in Norway with support from Scandinavian doctors.

From the manufacturer's own website. Source

What Diagnostica AS makes

Diagnostica AS manufactures PC-based medical systems for respiratory function testing, including spirometry devices like the Spirare Web and Spirare PC. These systems also incorporate ECG monitoring and ambulatory blood pressure measurement for continuous patient assessment.

The company’s devices fall under EU Class IIa classification and are registered in the EUDAQMED database. Diagnostica AS is based in Norway and adheres to relevant European medical device regulations.

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 Diagnostica AS manufacture?

Diagnostica AS produces PC-based medical systems designed for respiratory function testing, specifically spirometry devices such as the Spirare Web and Spirare PC. These systems also include integrated features for ECG monitoring and 24-hour blood pressure measurement, enabling comprehensive patient assessments in a single platform.

Where is Diagnostica AS based?

Diagnostica AS is headquartered in Norway, where it develops and manufactures its medical devices in compliance with European medical device regulations.

Which regulatory registries list Diagnostica AS’s devices?

Diagnostica AS’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of authorised devices within the EU market.

How are Diagnostica AS’s devices classified under EU regulations?

Diagnostica AS’s devices, including the Spirare Web and Spirare PC, are classified under EU Class IIa. This classification is determined based on their intended use and associated risk levels, requiring compliance with specific regulatory requirements to ensure safety and performance.

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

Information

Country
Norway
Address
19, Ostre Aker vei, Oslo, Norway
Phone
+4722924000
PRRC contact
Inger Louise Bones
EUDAMED SRN
NO-MF-000041375