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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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spinit® HbA1c control — 1 UDI-DI variant, IVDD (biosurfit SA)

MD Atlas
biosurfit SA

Data from EUDAMED, last updated May 30, 2026

spinit® HbA1c control

B-910301P8

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: biosurfit SA

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Device characteristics

ReagentNear-patient testingProfessional testingHuman tissues / cells

Identity & classification

Basic UDI-DI: B-910301P8
Device name: spinit® HbA1c control
Device model: spinit® HbA1c control
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: Oct 30, 2024

Manufacturer & authorised representative

Manufacturer

Name: biosurfit SA
SRN: PT-MF-000033920
Country: Portugal
Email: info@biosurfit.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01JBF475PHP5FH2BSKXBCEA221

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

spinit®D-910301P8