# EasyOne Sky Spirometer

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/easyone-sky-spirometer-bzg>
- Manufacturer: [NDD Medizintechnik AG](https://devicerts.com/manufacturers/ndd-medizintechnik-ag) (Switzerland)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: BZG
- EMDN: Z12150180 SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES
- GMDN: Diagnostic spirometer, professional (13680)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The EasyOne Sky Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced expiratory volume (FEV₁) and forced vital capacity (FVC). It provides objective data for assessing respiratory conditions, including obstructive and restrictive lung diseases, by evaluating airflow and volume during forced exhalation.

This portable, single-use device is intended for use in clinical and home settings, adhering to FDA 510(k) and MDR regulatory standards. Supplied in sterile packaging, it requires no additional sterilization and is compatible with standard medical environments. The device is classified under device class II and is authorized for use in anesthesia and pulmonary function testing, with registration number 8030978 under regulation 868.1840.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 764014219SpirometerBS · UDI-DI 07640142190554 · registered 2026-05-13 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07640142190554 · listed 2026-04-21 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K230178 · decision 2023-10-19 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: EasyOne Sky [EUDAMED]; EasyOne Sky Spirometer [FDA GUDID (AccessGUDID)]
- Generic name: Diagnostic spirometer, professional [FDA GUDID (AccessGUDID)]
- Device name: Spirometry Family [EUDAMED]
- Model / reference: 2800-1 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07640142190554 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 764014219SpirometerBS [EUDAMED]
- Direct marketing DI: 07640142190554 [EUDAMED]
- 510(k) Number: K230178 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: BZG [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z12150180 [EUDAMED]
- GMDN term: Diagnostic spirometer, professional (13680) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 868.1840 [FDA 510(k), FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: EasyOne Sky Spirometer, NDD Medizintechnik AG. deviCERTS medical device catalogue. https://devicerts.com/devices/easyone-sky-spirometer-bzg (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/easyone-sky-spirometer-bzg.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/easyone-sky-spirometer-bzg
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.