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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

TRIstar 4K — Class I MDR by ILO electronic GmbH

MD Atlas
ILO electronic GmbH

EUDAMED last updated this device on May 20, 2026

TRIstar 4K

42503697854P5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ILO electronic GmbH
UDI-DI code: 04250369706709
Reference / catalog number: 854-0029

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Manufacturer information

Organization name: ILO electronic GmbH
SRN: DE-MF-000005269
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 1, 2022	Still on market

Device identification

Trade name: TRIstar 4K
UDI-DI code: 04250369706709
Basic UDI-DI: 42503697854P5
Reference / catalog number: 854-0029
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 3x 1/3" CMOS-Sensor, Image resolution: UHD 3840 x 2160, 10 User presets
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020405SURGICAL CAMERAS

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

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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.