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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

OX7000-01 — IVDR Class A IVDR by BIOLAN MICROBIOSENSORES…

MD Atlas
BIOLAN MICROBIOSENSORES S.L.

EUDAMED last updated this device on Apr 27, 2026

OX7000-01

8437022705XYLDEV01BR

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOLAN MICROBIOSENSORES S.L.
UDI-DI code: 08437022705125
Reference / catalog number: OX7000-01

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Manufacturer information

Organization name: BIOLAN MICROBIOSENSORES S.L.
SRN: ES-MF-000001992
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 18, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437022705125
Basic UDI-DI: 8437022705XYLDEV01BR
Reference / catalog number: OX7000-01
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: OSAXYL Test Strips reader for quantifying xylose in urine and aiding in the diagnosis of lactase deficiency/lactose intolerance.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02010199CHEMISTRY INSTRUMENTS - OTHER

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

Related devices

OSAXYL Control KitB-08437022705156On the market OSAXYL Test StripsB-08437022705149On the market OSAXYL Test StripsB-08437022705132On 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.