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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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Calprosmart Self-Test — 1 UDI-DI variant, IVDD (Calpro AS)

MD Atlas
Calpro AS

Data from EUDAMED, last updated May 30, 2026

Calprosmart Self-Test

B-07090028592017

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — Self-testing

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — Self-testing
Manufacturer: Calpro AS

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Device characteristics

ReagentSelf-testing

Legacy certificates

Certificate number: C-02-1206-801-22
Type: refdata.legacy.ivdd-certificate-type.iii-6
Notified body: Eurofins Electric & Electronics Finland Oy (0537)
Validity: May 25, 2025

Identity & classification

Basic UDI-DI: B-07090028592017
Device name: Calprosmart Self-Test
Device model: CAL201
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — Self-testing
Version date: Feb 26, 2024

Manufacturer & authorised representative

Manufacturer

Name: Calpro AS
SRN: NO-MF-000036194
Country: Norway
Email: einar.mork@svarlifescience.com
Phone: +47 47285561

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01HQJPA7GX9YFYW1HCGW494V01

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

CalproSmart Self-Test07090028592017