CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS
Notified body SRN
0318
Notified body country
Spain
Covered devices
No specific devices are listed for this certificate.
Characteristics
Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others
History
No status changes or preceding certificates are recorded.
Scope coverage
Class IIa8Class III2
10 scopes
MDA 0312: Otros productos activos no implantables quirúrgicos / Other active non-implantable surgical devices
Class IIa
MDN 1202: Productos no activos y no implantables para la administración, conducción y extracción de sustancias, incluidos los de diálisis / Non -active non-implantable devices for administration, channeling and renoval of sustances, including devices for dialysis
Class IIa
MDN 1203:
Catéteres guía, catéteres de balón, guías, introductores, filtros e instrumentos relacionados no activos y no implantables / Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
Class III
Botellas Drenofast / Drenofast bottles
Class IIa
Sistema Drenofast / Drenofast system
Class IIa
Sondas Redón Drenofast / Drenofast Redon Drain
Class IIa
Agujas Drenofast / Drenofast Needles
Class IIa
Tubos accesorios Drenofast / Drenofast tubes
Class IIa
Conjunto de sondas + Aguja Drenofast / Drenofast set Redon drain and needle
Class IIa
Catéter de extracción de trombos / Thrombus extraction catheter