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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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Baxter Healthcare SA

Certificate G10 056740 0072

Rev. Rev. 00Issued
Valid until
Nov 5, 2029

Certificate G10 056740 0072 is a valid Quality management system issued to Baxter Healthcare SA and registered in EUDAMED. Valid until November 5, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
G10 056740 0072
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0123G10 056740 0072Rev. 00

Validity

Issued
Nov 6, 2024
Valid from
Nov 6, 2024
Valid until
Nov 5, 2029

Notified body

Notified body
TÜV SÜD Product Service GmbH
Notified body SRN
0123
Notified body country
Germany

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 IIa11Class IIb3

14 scopes

  • F020104 - REINFUSION DIALYSIS LINES
    Class IIb
  • F020104 - REINFUSION DIALYSIS LINES
    Class IIb
  • F020104 - REINFUSION DIALYSIS LINES
    Class IIb
  • B030201 - PLASMAPHERESIS DEVICES AND KITS
    Class IIa
  • C03010101 - EXTRACORPOREAL CIRCULATION CIRCUITS
    Class IIa
  • F020101 - ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE
    Class IIa
  • F020102 - ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES
    Class IIa
  • F020104 - REINFUSION DIALYSIS LINES
    Class IIa
  • F020180 - ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES
    Class IIa
  • F02020202 - TEMPORARY PERITONAEAL DIALYSIS LINES, WITH PUMP (APD)
    Class IIa
  • F020280 - PERITONAEAL DIALYSIS LINES - ACCESSORIES
    Class IIa
  • F900301 - HAEMODIALYSIS ADAPTORS
    Class IIa
  • F900302 - PERITONAEAL DIALYSIS ADAPTORS
    Class IIa
  • F9080 - DIALYSIS DEVICES - OTHER ACCESSORIES
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Baxter Healthcare SA
Manufacturer SRN
CH-MF-000026124
Manufacturer country
Switzerland