Laboratorios Grifols S.A.

Certificate 2023 CR 0002

Rev. 4Issued

Valid until: May 31, 2028

Certificate 2023 CR 0002 is a valid Quality management system issued to Laboratorios Grifols S.A. and registered in EUDAMED. Valid until May 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023 CR 0002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03182023 CR 00024

Validity

Issued: Mar 16, 2026
Valid from: Mar 16, 2026
Valid until: May 31, 2028

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: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I5Class IIb4Class IIa2

11 scopes

MDA 0318:Los demás productos activos no implantables /other active non-implantable 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, channelling and renoval of substances, including devices for dialysis.
Class I
MDN 1213 - Productos no activos y no implantables, compuestos de sustancias, destinados a ser introducidos en el cuerpo humano por un orificio corporal o por vía cutánea/ Non-active nonimplantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
Class IIb
Gri-Fill Peristaltic set
Class I
GriFill 2 Way Set
Class I
Gri-Fill 6 to 1 Set
Class I
Bolsas para sistema Gri- Fill Gri Bag
Class I
Vacuflasc
Class IIa
Agua para irrigación Grifols
Class IIb
Glicina al 1,5% Grifols
Class IIb
Salina fisiológica para irrigación Grifols
Class IIb

Scope coverage

Class I5Class IIb4Class IIa2

11 scopes

MDA 0318:Los demás productos activos no implantables /other active non-implantable 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, channelling and renoval of substances, including devices for dialysis.
Class I
MDN 1213 - Productos no activos y no implantables, compuestos de sustancias, destinados a ser introducidos en el cuerpo humano por un orificio corporal o por vía cutánea/ Non-active nonimplantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
Class IIb
Gri-Fill Peristaltic set
Class I
GriFill 2 Way Set
Class I
Gri-Fill 6 to 1 Set
Class I
Bolsas para sistema Gri- Fill Gri Bag
Class I
Vacuflasc
Class IIa
Agua para irrigación Grifols
Class IIb
Glicina al 1,5% Grifols
Class IIb
Salina fisiológica para irrigación Grifols
Class IIb

Certificate 2023 CR 0002

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Certificate 2023 CR 0002

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer

Documents