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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

BIOHIT FAEX Sample System — IVDR Class A IVDR by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Jan 31, 2025

BIOHIT FAEX Sample System

6419587BFX010TC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587349008
Reference / catalog number: 602610

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
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 Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: BIOHIT FAEX Sample System
UDI-DI code: 06419587349008
Basic UDI-DI: 6419587BFX010TC
Reference / catalog number: 602610
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: 250
Additional product description: BIOHIT FAEX Sample System is a sample collection tube intended for the collection, primary containment, preservation, and handling of human feces for further use in diagnostic methods in the laboratory. The tube is to be used by healthcare professionals and laypersons, either in laboratory, near-patient testing, or home environments. The device is a single-use specimen receptacle for in vitro diagnostic use.
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

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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.