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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

TMH-01 — IVDR Class A IVDR by MIRNAX BIOSENS S.L.

MD Atlas
MIRNAX BIOSENS S.L.

EUDAMED last updated this device on Apr 15, 2026

TMH-01

8447673TMH016J

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: MIRNAX BIOSENS S.L.
UDI-DI code: 08447673000005
Reference / catalog number: TMH-01

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Manufacturer information

Organization name: MIRNAX BIOSENS S.L.
SRN: ES-MF-000051105
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 1, 2026	Jun 6, 2029

Device identification

Trade name: not provided
UDI-DI code: 08447673000005
Basic UDI-DI: 8447673TMH016J
Reference / catalog number: TMH-01
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: El producto consiste en un kit de recogida de muestras fecales, con el que sujetos pueden realizar la recolección de la muestra sin supervisión de personal médico y realizar su envío posterior para el procesamiento de la muestra en el laboratorio de análisis clínico.
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
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Software identification

Related devices

This device is not currently linked to any other device.

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.