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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

K106 — IVDR Class A IVDR by "Bio-Ksel" Sp. z o.o.

MD Atlas
"Bio-Ksel" Sp. z o.o.

EUDAMED last updated this device on May 4, 2026

K106

59007482463bioksel61004D

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: "Bio-Ksel" Sp. z o.o.
UDI-DI code: 05900748246317
Reference / catalog number: K106

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View device family (Basic UDI)

Manufacturer information

Organization name: "Bio-Ksel" Sp. z o.o.
SRN: PL-MF-000004774
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Mar 29, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05900748246317
Basic UDI-DI: 59007482463bioksel61004D
Reference / catalog number: K106
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)05900748246317

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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.

W0202020102AUTOMATED COAGULOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

843 522B-05902186655218On 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.