AKERN S.r.l.

About Akern

AKERN S.r.l. has been developing and producing medical solutions for body composition measurement based on Bioimpedance Analysis (BIA) since 1980. The company, based in Pisa, manufactures and distributes analyzers such as BIA 101 BIVA PRO, BIA 101 MED, EFG+, NUTRILAB PRO, NUTRILAB, and TELELAB, along with related software and apps (including Bodygram). The products are used for real-time measurement of tissue electrical properties (Rz, Xc, and phase angle) as well as for assessing hydration and nutritional status. The entire production and distribution process is traceable via serial or batch numbers; every device is double-checked. Application fields include clinic and prevention, nutrition, and sports and fitness. With over 20,000 analyzers distributed worldwide and over 4,400 scientific publications, Akern has been part of the PharmaNutra S.p.A. Group since June 2022.

Site

Pisa

Processes

Training and information (education/training), Post-sales support (after-sales assistance), Research and clinical validation, Software and apps (Bodygram, Fitness, Regional)

Certificates

ISO 9001:2015, ISO 13485:2016, MDR (EU) 2017/745, Annex IX Chapter I, Class IIa, MDR (EU) 2017/745, Class IIa

Founded

1980

Industries

Medical technology, Clinic and prevention, Nutrition, Sports and fitness, Medical technology / Body Composition

1. 01

   Research and clinical validation

2. 02

   Development and design

3. 03

   Production of analyzers

4. 04

   Double final inspection (production and certification)

5. 05

   Market launch and distribution

6. 06

   Training and support

7. 07

   Post-sales support

Locations

Pisa

IT

Headquarters and administration

Pontassieve

IT

Certified production/operating site

Products

Inside the production

Quality

Every bioimpedance device produced is double-checked – upon exiting production and during certification; the inspection documentation is archived for at least five years. Quality assurance includes regulatory and functional testing, electromagnetic compatibility and electrical safety tests, stress tests on newer devices, as well as UDI/EUDAMED traceability in accordance with the MDR.

History

1. 1980

   Start of development of medical solutions for body composition measurement

2. 2017

   First certification according to ISO 9001 and ISO 13485 on 25.09.2017

3. 2022

   Akern becomes part of the PharmaNutra S.p.A. Group on 15.06.2022; Nutrilab approval as a medical device in the People's Republic of China on 26.08.2022

4. 2024

   Start of the EU co-funded project SVAAMAS2D1 (09/2024–06/2026, budget €368,625) for the 2D image analysis app

5. 2025

   First issuance of the MDR certificate IT345661 (01.09.2025) for BIA101 BIVA PRO, BIA101 MED, EFG+, NUTRILAB PRO, NUTRILAB, TELELAB

6. 2026

   Recertification according to ISO 9001 and ISO 13485 (audit 29.07.2026, valid until 25.09.2029)