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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

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

MD Atlas
Home Diagnostics S.L

EUDAMED last updated this device on Oct 25, 2022

04

843702490904EN

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: 08437024909040
Reference / catalog number: 04

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Manufacturer information

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

Critical warnings

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

CW275
If pregnant, or coagulation issue or if you are taking any anticoagulant meds
CW267
the yellow microtube contains a reactive of bovine origin
CW009
one use only
CW010
book information symbol in 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 FIRST AND DO NOT TAKE THE TEST ON YOUR OWN

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437024909040
Basic UDI-DI: 843702490904EN
Reference / catalog number: 04
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 04 es un kit para contener y preservar las muestras de sangre capilar y orina para ser analizados por un laboratorio externo y así facilitar el conocimiento y monitorización de un estado fisiológico de forma cuantitativa y cualitativa.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

01843702490901EGOn the market 02843702490902EJOn 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.