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Organization name
UDI-DI code
Reference / catalog number

BMVision Kidney — Class IIa MDR by Better Medicine OÜ

MD Atlas
Better Medicine OÜ

EUDAMED last updated this device on Apr 21, 2026

BMVision Kidney

426241806BetterVisionAIAX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Better Medicine OÜ
UDI-DI code: 04262418060014
Reference / catalog number: BMV-KIDNEY

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Manufacturer information

Organization name: Better Medicine OÜ
SRN: EE-MF-000034185
Manufacturer status: Active

Critical warnings

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

CW010
Consult Instructions for Use
CW011
Only for second or concurrent reader

Market distribution

Primary placement in Estonia; available across 1 country total.

Country	On market since	Until
EstoniaPrimary placement	Dec 2, 2025	Still on market

Device identification

Trade name: BMVision Kidney
UDI-DI code: 04262418060014
Basic UDI-DI: 426241806BetterVisionAIAX
Reference / catalog number: BMV-KIDNEY
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: AI-based radiology software for CT analysis of renal lesions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - 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

This device is not currently linked to any other device.

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.