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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

BLOTrix System 5/ BLOTrix Reader… — IVDR Class A IVDR

MD Atlas
BioSciTec GmbH

EUDAMED last updated this device on May 19, 2026

BLOTrix System 5/ BLOTrix Reader R2 L

42604972700022MW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BioSciTec GmbH
UDI-DI code: 04260497270614
Reference / catalog number: b55btrr2l

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Manufacturer information

Organization name: BioSciTec GmbH
SRN: DE-MF-000007888
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 26, 2026	Dec 31, 2031

Device identification

Trade name: BLOTrix System 5/ BLOTrix Reader R2 L
UDI-DI code: 04260497270614
Basic UDI-DI: 42604972700022MW
Reference / catalog number: b55btrr2l
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.

EMDN nomenclature code(s)

W0201069080VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification