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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

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

MD Atlas
Home Diagnostics S.L

EUDAMED last updated this device on Aug 10, 2022

02

843702490902EJ

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: 08437024909026
Reference / catalog number: 02

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Manufacturer information

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

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01843702490901EGOn the market 04843702490904ENOn the market 18843702490918EZOn the market REFERENCIA 14843702490914EROn the market REFERENCIA 11843702490911EKOn 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.

Critical warnings

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

CW275
If pregnant, or have a coagulation issue or if you are taking anticoagulant medication
CW267
The reactive in one of the microtubes is from animal origin
CW009
One use only
CW010
book information symbol in the packaging A
CW007
Crossed box symbol in instructions
CW032
date indicated in packaging
CW011
if you tend to feel dizzy when seeing blood, check with your doctor and do not use the kit on your own.

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: 08437024909026
Basic UDI-DI: 843702490902EJ
Reference / catalog number: 02
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: Ailin Kit referencia 02 es un kit para contener y preservar las muestras de sangre capilar para ser analizadas por un laboratorio externo y así facilitar el conocimiento y monitorización de un estado fisiológico de forma cuantitativa y cualitativa. REFERENCIA 2: << Kit para la auto toma de muestra de sangre capilar. Este kit contiene: 2 microtubos, 3 lancetas, 2 tiritas, 2 toallitas desinfectante, 1 bolsa de seguridad y 1 de bolsa de envío>>
Additional information URL: https://ailin.es/
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

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Software identification