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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

Spirare PC SPDSW0 — Class IIa MDR by Diagnostica AS

MD Atlas
Diagnostica AS

EUDAMED last updated this device on Mar 26, 2025

Spirare PC SPDSW0

709003245SPDSWAY

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Diagnostica AS
UDI-DI code: 07090032450013
Reference / catalog number: Spirare PC SPDSW0

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View device family (Basic UDI)

Manufacturer information

Organization name: Diagnostica AS
SRN: NO-MF-000041375
Manufacturer status: Active

Related devices

Spirare Web SPDWB0709003245SPDSWAYOn the market

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 2 countries total.

Country	On market since	Until
NorwayPrimary placement	Jan 1, 1994	Still on market
Sweden	Jan 1, 1996	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07090032450013
Basic UDI-DI: 709003245SPDSWAY
Reference / catalog number: Spirare PC SPDSW0
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: Spirare Client software installed on a PC
Additional information URL: https://www.spirare.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.