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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

REFERENCIA 13 — IVDR Class A IVDR by Home Diagnostics S.L

MD Atlas
Home Diagnostics S.L

EUDAMED last updated this device on Aug 21, 2024

REFERENCIA 13

843702490913EP

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Home Diagnostics S.L
UDI-DI code: 08437024909132
Reference / catalog number: REFERENCIA 13

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Manufacturer information

Organization name: Home Diagnostics S.L
SRN: ES-MF-000026858
Manufacturer status: Active

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW011
Este kit está destinado a personas con un peso superior a 25 kg
CW030
En caso de que sea diabético o sea alérgico a los ingredientes indicados en el etiquetado del sustrato, consulte con su médico antes de realizar la prueba. En caso de estar embarazada o sufrir de enfermedad pulmonar obstructiva crónica (EPOC), consulte con su médico antes de realizar la prueba. Este kit no está indicado para pacientes con intolerancia a la lactosa o fructosa hereditaria.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08437024909132
Basic UDI-DI: 843702490913EP
Reference / catalog number: REFERENCIA 13
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: ES UN KIT QUE CONTIENE COMPONENTES PARA LA EXTRACCIÓN Y TRANSPORTE DE MUESTRAS. EN ESTE CASO, ES UN KIT DE RECOGIDA DE AIRE ESPIRADO PARA SIBO POR LO QUE SE INCLUYE LACTOSA QUE HA DE TOMARSE ANTES DE SOPLAR EL AIRE EN LOS TUBOS.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

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

Related devices

01843702490901EGOn the market 02843702490902EJOn the market 04843702490904ENOn the market 18843702490918EZOn the market REFERENCIA 14843702490914EROn the market

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.