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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

5453_ — IVDR Class A IVDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Feb 3, 2025

5453_

353267F00185N8T

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532670103530
Reference / catalog number: 5453_

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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	Jan 28, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03532670103530
Basic UDI-DI: 353267F00185N8T
Reference / catalog number: 5453_
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: Non-automated specimen collection device and receptacle containing extraction buffer. The stool collection kit is designed for collection of a human stool sample containing an analyte to be further measured on a dedicated analyzer with specific validated assays.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019001FAECES COLLECTION DEVICES

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