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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

K-231004-000 — Class I MDR by SITIN LAB s.r.o.

MD Atlas
SITIN LAB s.r.o.

EUDAMED last updated this device on May 25, 2026

K-231004-000

859421190003GV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SITIN LAB s.r.o.
UDI-DI code: 08594211900034
Reference / catalog number: K-231004-000

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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-231005-004-V859421190007H5On the market K-231005-003859421190007H5On 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	Jan 28, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594211900034
Basic UDI-DI: 859421190003GV
Reference / catalog number: K-231004-000
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: Anatomical backrest (medium) – medical device primarily intended for installation into wheelchairs, to ensure a stable, anatomically comfortable and safe sitting for a wheelchair user. The backrest ensures postural stability, upright and symmetrical sitting with maximum distribution of pressure over the entire supporting part and maintaining the physiological curvature of the spine. The product is tailored for the user according to the targeting protocol.
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)08594211900034

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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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