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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

Aria Glucose Control Solution — IVDD — Annex II List B IVDD

MD Atlas
Biochemical Systems International S.p.A.

EUDAMED last updated this device on May 5, 2026

Aria Glucose Control Solution

B-08032937233697

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biochemical Systems International S.p.A.
UDI-DI code: 08032937233697
Reference / catalog number: 3880020E

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View device family (Basic UDI)

Manufacturer information

Organization name: Biochemical Systems International S.p.A.
SRN: IT-MF-000028905
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Aug 1, 2021	Still on market
Malta	Aug 1, 2021	Still on market

Device identification

Trade name: Aria Glucose Control Solution
UDI-DI code: 08032937233697
Basic UDI-DI: B-08032937233697
Reference / catalog number: 3880020E
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Aria control solutions can only be used with the Aria strips and meter to check that the meter and strips are working together as a system and that you are performing the test correctly, without the need to use your own blood. It is very important to use the control solutions periodically to check that the results are accurate.
Additional information URL: https://www.biosys.it/it/prodotto-aria/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032937233697

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W010106010801BLOOD TEST STRIPS CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

3830003ROB-08032937233666On the market Aria Blood Glucose Systems Kit - EnglishB-08032937233567On the market 3880005GB-08032937233208On the market 3880020B-08032937233642On the market Aria Glucose Test Strips 25pzB-08032937233604On 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.