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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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axion GmbH

Certificate C563995

Rev. 1Issued
Valid until
Jul 12, 2029

Overview

Certificate number
C563995
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
2460C5639951

Validity

Issued
Jul 12, 2024
Valid from
Jul 12, 2024
Valid until
Jul 12, 2029

Manufacturer

Manufacturer
axion GmbH
Manufacturer SRN
DE-MF-000006487
Manufacturer country
Germany

Notified body

Notified body
DNV Product Assurance AS
Notified body SRN
2460
Notified body country
Norway

Covered devices

No specific devices are listed for this certificate.

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
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa5

5 scopes

  • Transcutaneous & Muscle Electrical Nerve Stimulators Transcutaneous Electrical Nerve
    Class IIa
  • Transcutaneous Electrical Nerve Stimulators (T.E.N.S.) - STIM-PRO Comfort+
    Class IIa
  • Transcutaneous Electrical Nerve Stimulators (T.E.N.S.) - STIM-PRO Eco
    Class IIa
  • Transcutaneous Electrical Nerve Stimulators (T.E.N.S.) & Electrical Muscle Stimulation (E.M.S.) - STIMPRO X9B
    Class IIa
  • Electrical Muscle Stimulation (E.M.S.) - STIM-PRO I-3000
    Class IIa

Documents

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