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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

BILIRUBIN DIRECT — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Jan 20, 2026

BILIRUBIN DIRECT

37017008BIDI004A

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700817307
Reference / catalog number: BIDI-0500

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Manufacturer information

Organization name: VitalScientific
SRN: FR-MF-000004722
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.

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	Jun 6, 2024	Still on market

Device identification

Trade name: BILIRUBIN DIRECT
UDI-DI code: 03701700817307
Basic UDI-DI: 37017008BIDI004A
Reference / catalog number: BIDI-0500
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: "BILIRUBIN DIRECT is an in vitro diagnostic reagent intended for the quantitative determination of direct bilirubin in human serum and plasma samples on analyzers or semi-automatic analyzers. These in vitro diagnostic devices are 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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