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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

Carebot AI MMG — Class IIa MDR by Carebot s.r.o.

MD Atlas
Carebot s.r.o.

EUDAMED last updated this device on Apr 1, 2026

Carebot AI MMG

859421891AIMMGKP

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Carebot s.r.o.
UDI-DI code: 08594218910036
Reference / catalog number: Carebot AI MMG

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Manufacturer information

Organization name: Carebot s.r.o.
SRN: CZ-MF-000033696
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Mar 31, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594218910036
Basic UDI-DI: 859421891AIMMGKP
Reference / catalog number: Carebot AI MMG
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: Software as a Class IIa medical device using artificial intelligence for the evaluation of digital mammographic images
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Carebot AI Bones859421891AIBONESU3On the market Carebot AI CXR859421891AICXRKUOn the market

Certificates

Certificate health across this manufacturer's portfolio.

24 0097 QR/NBSupplemented
Quality management systemNotified body: 1023Expiry: Mar 13, 2029