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Airsonett AIR-4

by Airsonett AB United States EUDAMED510(k)GUDID

510(k) K130702Ref A-1000Model Air4 Product code FRFEMDN V9099

Overview

The Airsonett Air-4 is a Medical Recirculating Air Cleaner, classified as a Class II device under FDA regulations. It is designed to purify and recirculate air in clinical environments by removing airborne contaminants, including bacteria, viruses, and particulate matter, through high-efficiency filtration and airflow circulation.

This device is intended for use in general hospital settings, including operating rooms, patient care areas, and other controlled environments requiring clean air. Supplied as a reusable system, it requires proper installation, maintenance, and adherence to manufacturer guidelines for optimal performance. The Air-4 operates under FDA 510(k) clearance and MDR compliance, ensuring adherence to regulatory standards for medical air purification.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735012875AIR49P Basic UDI-DIDate22 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07350128750015 UDI-DIDate1 Feb 2023ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130702 Date23 Jul 2013ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 19 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 19 Oct 2026

Generic Name
Mobile laminar airflow unit
Device Name
Airsonett Air4
Model / Reference
Air4 EUDAMED
A-1000 EUDAMED
4 GUDID
Primary DI / UDI-DI
07350128750015
Basic UDI-DI
735012875AIR49P
Direct Marketing DI
07350128750015
510(k) Number
FDA Product Code
FRF
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Mobile laminar airflow unit
Device Class
Class I EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 880.5045
Market of Registration
Sweden
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
Air4
A-1000
510(k)
n/a
GUDID
4
Device ClassEUDAMED
Class I
510(k)
Class II
GUDID
Class II

Other devices from Airsonett AB

Questions

  • What types of clinical environments is the Airsonett Air-4 specifically designed for, and how does it improve air quality in those spaces?

    The Airsonett Air-4 is designed for general hospital settings, including operating rooms and patient care areas where maintaining clean air is critical. It purifies and recirculates air by removing airborne contaminants like bacteria, viruses, and particulate matter through high-efficiency filtration and airflow circulation, ensuring a controlled environment with reduced risk of airborne infections.

  • Is the Airsonett Air-4 a single-use or reusable device, and what maintenance is required to keep it functioning properly?

    The Airsonett Air-4 is a reusable system, meaning it is built to be installed and maintained over time rather than discarded after use. Proper installation, regular maintenance, and adherence to the manufacturer’s guidelines are essential to ensure optimal performance and longevity of the device.

  • How does the Airsonett Air-4 comply with regulatory standards, and what does its classification as a Class II device under FDA regulations mean for its use?

    The Airsonett Air-4 operates under FDA 510(k) clearance and MDR compliance, ensuring it meets stringent regulatory standards for medical air purification. Its classification as a Class II device indicates it has a moderate level of risk and requires special controls beyond general controls to ensure safety and effectiveness in clinical environments.

  • What does the advisory committee description “General Hospital” indicate about the intended use of the Airsonett Air-4?

    The advisory committee description ‘General Hospital’ refers to the submission process and does not define the device’s clinical indication. Instead, it confirms the device was reviewed by the FDA’s Orthopaedics and Rehabilitation Devices Panel (HO) as part of its 510(k) clearance process for medical recirculating air cleaners intended for use in hospital settings.

Properties & raw data

Show properties, registry sources and raw records
  • Over-the-Counter
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • FDA 510(k) K130702 24 fields · synced 19 Oct 2026
  • FDA UDI 6155874c-a971-49d0-a89d-163504a99814 34 fields · synced 29 May 2026
  • EUDAMED 07350128750015|735012875AIR49P 61 fields · synced 20 Jun 2026