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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

Workspace+ — Class IIa MDR by MVision AI Oy

MD Atlas
MVision AI Oy

EUDAMED last updated this device on Oct 21, 2025

Workspace+

642983006424WS1.0ZQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MVision AI Oy
UDI-DI code: 06429830064244
Reference / catalog number: 06429830064244

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Manufacturer information

Organization name: MVision AI Oy
SRN: FI-MF-000013082
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
This device to sale by or on the order of a licensed healthcare practitioner.
CW999
Workspace+ utilizes machine learning-based algorithms, which inherently carry risks of bias. While extensively validated, artificial intelligence (AI) systems may perform differently for patient populations or anatomical variations underrepresented in training datasets. Thorough review of all generated outputs by qualified professionals before clinical use is essential to identify any potential AI bias effects that could impact treatment planning quality. Users are responsible for the radiotherapy workflow and controlling risk related to changes to that workflow when using this device.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Sep 19, 2025	Still on market

Device identification

Trade name: Workspace+
UDI-DI code: 06429830064244
Basic UDI-DI: 642983006424WS1.0ZQ
Reference / catalog number: 06429830064244
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11010292INSTRUMENTS FOR RADIOTHERAPY SIMULATION - MEDICAL DEVICE SOFTWARE

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.