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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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Wearable Robotics s.r.l.

Certificate MDR 00153-A

Rev. 0Issued
Valid until
Sep 21, 2030

Certificate MDR 00153-A is a valid Quality management system issued to Wearable Robotics s.r.l. and registered in EUDAMED. Valid until September 21, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
MDR 00153-A
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0476MDR 00153-A0

Validity

Issued
Sep 22, 2025
Valid from
Sep 22, 2025
Valid until
Sep 21, 2030

Notified body

Notified body
KIWA CERMET ITALIA S.P.A.
Notified body SRN
0476
Notified body country
Italy

Characteristics

Sterile
No
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
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

  • Z120690
    Class IIa
  • DEVICE
    Class IIa

Manufacturer

Manufacturer
Wearable Robotics s.r.l.
Manufacturer SRN
IT-MF-000035444
Manufacturer country
Italy

Covered devices

  • Arm Light Exoskeleton Rehab StationClass IIa
    805257513000BA

Documents

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