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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

Dose+ — Class IIa MDR by MVision AI Oy

MD Atlas
MVision AI Oy

EUDAMED last updated this device on Mar 14, 2025

Dose+

642983006423Dose1.0DH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MVision AI Oy
UDI-DI code: 06429830064237
Reference / catalog number: 06429830064237

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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
Dose+ provides predicted dose distributions and optimization objectives intended only as starting points to assist in treatment planning optimization. The device does not make or recommend final clinical decisions. All outputs must be reviewed, optimized, and approved by qualified radiation therapy professionals according to standard clinical protocols before treatment delivery. Direct use without proper review could result in suboptimal treatment plans. The radiation therapy professional using this device maintains full responsibility for all clinical decisions, treatment plans, and therapeutic outcomes. Documentation of plan review and approval must follow established institutional procedures and regulatory requirements.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Mar 14, 2025	Still on market

Device identification

Trade name: Dose+
UDI-DI code: 06429830064237
Basic UDI-DI: 642983006423Dose1.0DH
Reference / catalog number: 06429830064237
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

Contour+ (MVision AI Segmentation)64298300642AISEG1.2SZOn the market MVision Segmentation ServiceB-06429830064206On the market Workspace+642983006424WS1.0ZQOn the market

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.