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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 16 — IVDR Class A IVDR by Home Diagnostics S.L

MD Atlas
Home Diagnostics S.L

EUDAMED last updated this device on Jan 21, 2025

REFERENCIA 16

843702490916EV

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: 08437024909163
Reference / catalog number: REFERENCIA 16

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Manufacturer information

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

Critical warnings

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

CW275
INSTRUCCIONES
CW011
ETIQUETADO E INSTRUCCIONES
CW010
ETIQUETADO
CW009
ETIQUETADO E INSTRUCCIONES
CW032
ETIQUETADO

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: 08437024909163
Basic UDI-DI: 843702490916EV
Reference / catalog number: REFERENCIA 16
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: KIT PARA LA AUTOTOMA Y TRANSPORTE DE MUESTRAS DE AIRE ESPIRADO PARA LA INTOLERANCIA A LA FRUCTOSA
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.