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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

08594225430015 — Class IIa MDR by MAIA LABS s.r.o.

MD Atlas
MAIA LABS s.r.o.

EUDAMED last updated this device on May 26, 2026

08594225430015

859422543ColoMaiaIINK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MAIA LABS s.r.o.
UDI-DI code: 08594225430015
Reference / catalog number: 08594225430015

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View device family (Basic UDI)

Manufacturer information

Organization name: MAIA LABS s.r.o.
SRN: CZ-MF-000044767
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Before first use, read instruction for use.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	May 25, 2026	May 25, 2031

Device identification

Trade name: not provided
UDI-DI code: 08594225430015
Basic UDI-DI: 859422543ColoMaiaIINK
Reference / catalog number: 08594225430015
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: The Al-based software ColoMaia I is intended to assist qualified physicians - gastroenterologists - in the detection of colonic mucosal lesions (especially polyps and adenomas) in real time during standard colonoscopic examination and in the retrospective analysis of colonoscopy recordings.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08594225430015

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

G030701GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES

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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Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

2026-MDR/QS-027Issued
Quality management systemNotified body: 2265Expiry: May 25, 2031