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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

BioLyse-FD1 SYS WBC-4-diff… — IVDR Class A IVDR by Bioxol Kft

MD Atlas
Bioxol Kft

EUDAMED last updated this device on Feb 7, 2023

BioLyse-FD1 SYS WBC-4-diff reagent 1L

5999862176BioL-FD1SYS5P

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Bioxol Kft
UDI-DI code: 05999862176518
Reference / catalog number: SY-2028

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Manufacturer information

Organization name: Bioxol Kft
SRN: HU-MF-000025409
Manufacturer status: Active

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: BioLyse-FD1 SYS WBC-4-diff reagent 1L
UDI-DI code: 05999862176518
Basic UDI-DI: 5999862176BioL-FD1SYS5P
Reference / catalog number: SY-2028
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: https://www.bioxol.net/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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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.