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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

DIRECT BILIRUBIN — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Sep 10, 2025

DIRECT BILIRUBIN

37017008BIDI014C

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700801801
Reference / catalog number: BIDI-M430

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Manufacturer information

Organization name: VitalScientific
SRN: FR-MF-000004722
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: DIRECT BILIRUBIN
UDI-DI code: 03701700801801
Basic UDI-DI: 37017008BIDI014C
Reference / catalog number: BIDI-M430
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: This in vitro diagnostic reagent is intended for the quantitative determination of direct bilirubin in human serum and plasma samples on Selectra Mach Series analyzers. This in vitro diagnostic reagent is for professional use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010203BILIRUBIN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.