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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

67465 — IVDD — General IVDD by Aidian Oy

MD Atlas
Aidian Oy

EUDAMED last updated this device on Mar 14, 2024

67465

B-06438115000259

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Aidian Oy
UDI-DI code: 06438115000259
Reference / catalog number: 67465

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Manufacturer information

Organization name: Aidian Oy
SRN: FI-MF-000023611
Manufacturer status: Active

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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

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06438115000259
Basic UDI-DI: B-06438115000259
Reference / catalog number: 67465
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The product is a manual, semi-quantitative test for the detection of viable microbes in urine samples. Urinary tract infection (UTI) is one of the most common infections caused by bacteria. Bacterial culture of an appropriately collected and handled urine sample aids in the accurate diagnosis of UTI. The test is intended to be used by healthcare professionals in the clinical laboratory and near-patient testing (NPT) setting (also known as point-of-care setting). For in vitro diagnostic use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010703URINE SCREENING MANUAL (DIPSLIDES ETC.)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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