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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

spinit® — IVDD — General IVDD by biosurfit SA

MD Atlas
biosurfit SA

EUDAMED last updated this device on Feb 16, 2024

spinit®

B-540300NK

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: biosurfit SA
UDI-DI code: D-540300NK
Reference / catalog number: 540300

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View device family (Basic UDI)

Manufacturer information

Organization name: biosurfit SA
SRN: PT-MF-000033920
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.

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Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: spinit®
UDI-DI code: D-540300NK
Basic UDI-DI: B-540300NK
Reference / catalog number: 540300
Issuing entity: EUDAMED

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 spinit® HbA1c disc is a disposable in vitro diagnostic medical device. It is a single use test, used with the spinit® instrument to aid in diagnosing and monitoring diabetes and identifying patients at risk of developing diabetes by quantitatively determining the concentration of glycated haemoglobin A1c in capillary whole blood samples of human origin. As an alternative to capillary blood, venous whole blood of human origin can be used. This is a device for near-patient testing and is only to be use by healthcare professionals.
Additional information URL: https://www.biosurfit.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

W0102060109GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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