Statistics for Digitalis

1Total Devices

1Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Digitalis

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Digitalis

Showing 1–1 of 1 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Clinical Rules	`2`	`D-10023674ClinicalRulesRY`	1	On the market

Device families (Basic UDI-DI) of Digitalis

Showing 1–1 of 1 device families.

Clinical RulesB-10023674ClinicalRulesRY

Market presence of Digitalis

Devices placed in 1 country

Netherlands1

EUDAMED update: Mar 26, 2026

Digitalis Mx BV

NL-MF-000048580

Active

Address: Papiermolen, 36 3994 DK Houten
Role: Manufacturer
Date of registration: Jul 8, 2025
Country: NL Netherlands

About Digitalis

SRN: NL-MF-000048580
Role: Manufacturer
Country: Netherlands
Organization name: Digitalis Mx BV
EU VAT number: NL817560415B01
Trade register: 34265526
Date of registration: Jul 8, 2025

Contact details for Digitalis

Address: 36, PAPIERMOLEN 3994 DK HOUTEN NETHERLANDS
Phone: +31 20 575 46 60
Email: digitalis@digitalis.nl
Website: www.digitalis.nl

Validator

Name: Ministerie van Volksgezondheid, Welzijn en Sport
SRN: NL-CA-058
Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Digitalis

ROOVERS Ricardo
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); (d) the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled;
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