Statistics for Sunrise SA

3Total Devices

2Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Sunrise SA

No certificates registered for this manufacturer.

Showing 1–3 of 3 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Sunrise sensor	`A201`	`05430001896121`	1	On the market
Sunrise sensor	`A200`	`05430001896008`	1	On the market
Sunrise Sleep Disorder Diagnostic Aid	`SUN1xx`	`05430001896015`	1	On the market

Devices placed in 1 country

MD Atlas update: May 27, 2026

BE-MF-000000105

Active

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
SRN: BE-CA-007
Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

ROY Cécile
• The conformity of the devices in accordance with the QMS under which the devices are manufactured, before a device is released; • The post-market surveillance obligations are complied with in accordance with Article 10(10); • The reporting obligations referred to in Articles 87 to 91 are fulfilled;
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MARTINOT Pierre
• The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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