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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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Distalmotion SA

Certificate HU24/00000124

Rev. 1Issued
Valid until
Oct 15, 2029

Overview

Certificate number
HU24/00000124
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1639HU24/000001241

Validity

Issued
Oct 15, 2024
Valid from
Oct 15, 2024
Valid until
Oct 15, 2029

Manufacturer

Manufacturer
Distalmotion SA
Manufacturer SRN
CH-MF-000037226
Manufacturer country
Switzerland

Notified body

Notified body
SGS Belgium NV
Notified body SRN
1639
Notified body country
Belgium

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 I2

2 scopes

  • MDN1208, MDS1005
    Class I
  • Sterile Interface (single use) for Dexter L6 system
    Class I

Documents

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