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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 0071

Rev. Rev. 00Issued
Valid until
Sep 2, 2029

Overview

Certificate number
G10 056740 0071
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0123G10 056740 0071Rev. 00

Validity

Issued
Sep 3, 2024
Valid from
Sep 3, 2024
Valid until
Sep 2, 2029

Manufacturer

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

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 IIb1

1 scope

  • B030299 - APHERESIS THERAPY DEVICES - OTHER
    Class IIb

Documents

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