Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

BioLyse CD Lysing reagent 5L — IVDR Class A IVDR by Bioxol Kft

MD Atlas
Bioxol Kft

EUDAMED last updated this device on Jan 31, 2023

BioLyse CD Lysing reagent 5L

5999862176BioLyseCDBB

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: 05999862176105
Reference / catalog number: CD-2043

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

BioClean AX Cleaning reagent 1L5999862176BioCleanAXAEOn the market BioClean AX Cleaning reagent 5L5999862176BioCleanAXAEOn the market BioClean CD Cleaning reagent 10L5999862176BioCleanCD9COn the market BioClean CD Cleaning reagent 20L5999862176BioCleanCD9COn the market BioClean cleaning reagent 1L5999862366BioClean3KOn 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.

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 CD Lysing reagent 5L
UDI-DI code: 05999862176105
Basic UDI-DI: 5999862176BioLyseCDBB
Reference / catalog number: CD-2043
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
Manufacturing date
Serial number
Software identification