SIBEL SAU

Spain Last updated 8 Jun 2026

Devices: 111
Registries: EUDAMED
FDA recalls: 0

Catalogue111

Page 3 of 3

Software W50 Ref 03024

Class IIa EUDAMED Active
Software SomniLab Ref 09894

Class IIa EUDAMED Active
Somnibel Ref 09892

Class IIa EUDAMED Active
HG2 cajas Ref 00551

Class I EUDAMED Active
Sistema Datospir Touch Easy-T COSMED Ref 10107-S

Class IIa EUDAMED Active
Sistema Datospir Touch Easy-D Ref 09877-S

Class IIa EUDAMED Active
Datospir Touch Easy-F Ref 09878

Class IIa EUDAMED Active
Sistema Somnibel Ref 09892-S

Class IIa EUDAMED Active
Módulo Transductor Turbina COSMED Ref 10110

Class IIa EUDAMED Active
Jeringa S3000 Ref 08290

Class I EUDAMED Active
HM4 bolsa-tiras Ref 02053

Class I EUDAMED Active

Showing 101-111 of 111

EUDAMED certificates1

Notified body 0318 1 certificate

2024 CR 0025 Supplemented

Quality management system EU MDR

Issued
30 Sep 2026

Expires
20 Jun 2029

Reason
Add device or group

Notified bodies

Notified body 0318

About

Sibelmed manufactures, commercializes and provides a post-sales service of spirometers, audiometers, audiometric cabins, respiratory polygraphs and sleep therapy

Translated from the manufacturer's own website. Source

Information

Address: 6-8, Raimon Casellas, Sabadell, Spain
Website: www.sibelmed.com
LinkedIn: linkedin.com/company/sibelgroup
Email: [email protected]
Phone: +34934360008(from company website)
EUDAMED SRN: ES-MF-000000287

Catalogue111

Software W50 Ref 03024

Software SomniLab Ref 09894

Somnibel Ref 09892

HG2 cajas Ref 00551

Sistema Datospir Touch Easy-T COSMED Ref 10107-S

Sistema Datospir Touch Easy-D Ref 09877-S

Datospir Touch Easy-F Ref 09878

Sistema Somnibel Ref 09892-S

Módulo Transductor Turbina COSMED Ref 10110

Jeringa S3000 Ref 08290

HM4 bolsa-tiras Ref 02053

EUDAMED certificates1

Notified body 0318 ·1 certificate

Related companies

Notified bodies

About

Information

Notified body 0318 1 certificate