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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

4828_ — IVDD — General IVDD by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on May 20, 2026

4828_

B-03532678603551

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678603551
Reference / catalog number: 4828_

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Manufacturer information

Organization name: BIOSYNEX
SRN: FR-MF-000014073
Manufacturer status: Active

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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: not provided
UDI-DI code: 03532678603551
Basic UDI-DI: B-03532678603551
Reference / catalog number: 4828_
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Homogeneous assay that uses a fluorescence resonance energy transfer (FRET) signal to detect the presence and quantity of IFX.
Additional information URL: https://www.biosynex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102080701INFLIXIMAB

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

Certificates

Certificate health across this manufacturer's portfolio.

030/MDRIssued
Quality management systemNotified body: 0051Expiry: Jun 5, 2027
G10 002187 0009Issued
Quality management systemNotified body: 0123Expiry: Sep 25, 2028