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Organization name
UDI-DI code
Reference / catalog number

K-231005-004-V — Class I MDR by SITIN LAB s.r.o.

MD Atlas
SITIN LAB s.r.o.

EUDAMED last updated this device on May 26, 2026

K-231005-004-V

859421190007H5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SITIN LAB s.r.o.
UDI-DI code: 08594211900102
Reference / catalog number: K-231005-004-V

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View device family (Basic UDI)

Manufacturer information

Organization name: SITIN LAB s.r.o.
SRN: CZ-MF-000023036
Manufacturer status: Active

Related devices

K-231006-000859421190005GZOn the market K-231009-000859421190006H3On the market K-231005-004859421190007H5On the market K-231005-003859421190007H5On the market K-231001-000-X859421190001GROn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594211900102
Basic UDI-DI: 859421190007H5
Reference / catalog number: K-231005-004-V
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: 2
Additional product description: Medical device accessories (large, adjustable, extendable side supports) - optional accessories for GEMINI seating and support systems.
Additional information URL: https://www.geminisystem.cz/
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)08594211900102

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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.

Y122499WHEELCHAIRS ACCESSORIES - OTHER

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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