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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

4853_ — IVDD — General IVDD by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on May 7, 2026

4853_

B-03532678603520

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678603520
Reference / catalog number: 4853_

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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: 03532678603520
Basic UDI-DI: B-03532678603520
Reference / catalog number: 4853_
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: A time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in human capillary whole blood collected by finger prick, venous whole blood, and venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.
Additional information URL: https://www.biosynex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102080702ADALIMUMAB

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