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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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CARDIVAIS S.A.

Certificate 2025 PR 0047

Rev. 2Issued
Valid until
Apr 20, 2030

Overview

Certificate number
2025 PR 0047
Certificate type
Quality assurance
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
03182025 PR 00472

Validity

Issued
Mar 3, 2026
Valid from
Mar 3, 2026
Valid until
Apr 20, 2030

Notified body

Notified body
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
No
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 I6

6 scopes

  • MDN 1214: Productos no activos y no implantables generales utilizados en la asistencia sanitaria y demás productos no activos y no implantables / General non-active non-implantable devices used in health care an other non-active non-implantable devices
    Class I
  • Batas Protectoras
    Class I
  • Batas Quirúrgicas
    Class I
  • Paños y Campos Quirúrgicos
    Class I
  • Fundas cubre-instrumentos
    Class I
  • Sets- Quirúrgicos
    Class I

Documents

LanguagesENES

Manufacturer

Manufacturer
CARDIVAIS S.A.
Manufacturer SRN
ES-MF-000017980
Manufacturer country
Spain