SURGIVAL CO., S.A.U.

Certificate 2024 CR 0015

Rev. 10Supplemented

Valid until: Feb 5, 2029

Certificate 2024 CR 0015 is a valid Quality management system issued to SURGIVAL CO., S.A.U. and registered in EUDAMED. Valid until February 5, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024 CR 0015
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 03182024 CR 001510

Validity

Issued: Apr 29, 2026
Valid from: Apr 29, 2026
Valid until: Feb 5, 2029

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: No
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

2024 CR 0015Quality management systemIssuedNov 8, 2024 → Feb 5, 2029

Scope coverage

Class IIb18Class III13

31 scopes

MDN 1102: Implantes óseos y ortopédicos no activos/Non-active osteo and orthopaedic implants
Class III
MDN 1102: Implantes óseos y ortopédicos no activos/Non-active osteo and orthopaedic implants
Class IIb
Prótesis AUSTIN MOORE no cementada/AUSTIN MOORE cementless prosthesis
Class III
Vástago de revisión/Revision stem recto no cementado/straight cementless/offset no cementado/offset cementless
Class IIb
Aumento femoral/Femoral augmentation:posterior cementado/Posterior cemented/distal cementado/ distal cemented
Class IIb
Aumento tibial cementado/Cemented tibial augmentation
Class IIb
Sistema Placa Tubo/Tube-plate system
Class IIb
Tornillo canulado pie SURGIFEET/Cannulated foot screw
Class IIb
Tornillo tipo weil SURGIFEET/ Weil-type screw SURGIFEET
Class IIb
Tornillo cortical/Cortical screw
Class IIb
Tornillo Esponjosa/Cancellous screw
Class IIb
Agujas Kirschner/ Kirschner wires
Class IIb
Clavos Steinman/ Steinman pins
Class IIb
Alambres de cerclaje/Cerclage Wires
Class IIb
Grapa americana para ligamento/ American staple for ligament
Class IIb
Grapa Blount/Blount staple
Class IIb
Grapa osteotomia escalón/Osteotomy staple-stepped
Class IIb
Grapa H. ros/ H.ros staple
Class IIb
Grapa para pie SURGIFEET/ SURGIFEET foot staple
Class IIb
Tornillo trasacetabular de cotilo/ Transacetabular cup screw
Class IIb

1 / 2

Scope coverage

Class IIb18Class III13

31 scopes

MDN 1102: Implantes óseos y ortopédicos no activos/Non-active osteo and orthopaedic implants
Class III
MDN 1102: Implantes óseos y ortopédicos no activos/Non-active osteo and orthopaedic implants
Class IIb
Prótesis AUSTIN MOORE no cementada/AUSTIN MOORE cementless prosthesis
Class III
Vástago de revisión/Revision stem recto no cementado/straight cementless/offset no cementado/offset cementless
Class IIb
Aumento femoral/Femoral augmentation:posterior cementado/Posterior cemented/distal cementado/ distal cemented
Class IIb
Aumento tibial cementado/Cemented tibial augmentation
Class IIb
Sistema Placa Tubo/Tube-plate system
Class IIb
Tornillo canulado pie SURGIFEET/Cannulated foot screw
Class IIb
Tornillo tipo weil SURGIFEET/ Weil-type screw SURGIFEET
Class IIb
Tornillo cortical/Cortical screw
Class IIb
Tornillo Esponjosa/Cancellous screw
Class IIb
Agujas Kirschner/ Kirschner wires
Class IIb
Clavos Steinman/ Steinman pins
Class IIb
Alambres de cerclaje/Cerclage Wires
Class IIb
Grapa americana para ligamento/ American staple for ligament
Class IIb
Grapa Blount/Blount staple
Class IIb
Grapa osteotomia escalón/Osteotomy staple-stepped
Class IIb
Grapa H. ros/ H.ros staple
Class IIb
Grapa para pie SURGIFEET/ SURGIFEET foot staple
Class IIb
Tornillo trasacetabular de cotilo/ Transacetabular cup screw
Class IIb

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Certificate 2024 CR 0015

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Certificate 2024 CR 0015

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer

Documents