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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

NVD-02 — Class IIa MDR by NuvoAir AB

MD Atlas
NuvoAir AB

EUDAMED last updated this device on Sep 18, 2025

NVD-02

735000263NVD022F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NuvoAir AB
UDI-DI code: 07350002630099
Reference / catalog number: NVD-02

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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.

CW011
Spirometry should be discontinued if you experience pain during the maneuver. The following acute and chronic contraindications do not preclude spirometry but should be discussed with your healthcare professional before you perform a maneuver.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Oct 2, 2023	Oct 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 07350002630099
Basic UDI-DI: 735000263NVD022F
Reference / catalog number: NVD-02
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Air Next spirometer (including firmware) is intended to perform basic lung function and spirometry testing.
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)07350002630099

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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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

Air NextB-07350002630020On the market NuvoAir HomeB-07350002630051On the market NVD-02735000263NVD022FOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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