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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Air Next — Class IIa MDD by NuvoAir AB

MD Atlas
NuvoAir AB

EUDAMED last updated this device on May 13, 2026

Air Next

B-07350002630020

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NuvoAir AB
UDI-DI code: 07350002630020
Reference / catalog number: NVD-01

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View device family (Basic UDI)

Manufacturer information

Organization name: NuvoAir AB
SRN: SE-MF-000005645
Manufacturer status: —

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Dec 31, 2028

Device identification

Trade name: Air Next
UDI-DI code: 07350002630020
Basic UDI-DI: B-07350002630020
Reference / catalog number: NVD-01
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Air Next is intended to measure the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function. Air Next is intended to be used by: • Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and ≥ 110 cm. • Adults trained by healthcare professionals ”competent adults”). Competent adult can assist a child who is ≥5 years old, >10kg and ≥110 cm. The actual diagnosis shall be done by a healthcare professional so home use is only for indicative purpose.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350002630020

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12150101CLINICAL/DIAGNOSTIC SPIROMETERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

NuvoAir HomeB-07350002630051On the market NVD-02735000263NVD022FOn the market NVD-02735000263NVD022FOn the market

Certificates

Certificate health across this manufacturer's portfolio.

FI23/00000051Issued
Quality management systemNotified body: 0598Expiry: Oct 1, 2028