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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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Diappymed

Certificate 21M00147CRT01

Rev. 21M00147CRT02Amended
Valid until
Oct 4, 2028

Overview

Certificate number
21M00147CRT01
Certificate type
Quality management system
Certificate status
Amended
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
191221M00147CRT0121M00147CRT02

Validity

Issued
Oct 4, 2023
Valid from
Oct 4, 2023
Valid until
Oct 4, 2028

Manufacturer

Manufacturer
Diappymed
Manufacturer SRN
FR-MF-000014110
Manufacturer country
France

Notified body

Notified body
Kiwa Assurance B.V.
Notified body SRN
1912
Notified body country
Netherlands

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
No
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
No
QMS/MOS type
Class IIb only

History

Status changes

  • Amended

Supersedes

  • 21M00147CRT01Quality management systemIssuedOct 4, 2023 → Oct 4, 2028

Scope coverage

Class IIb2

2 scopes

  • MDA 0315
    Class IIb
  • EkiYou
    Class IIb

Documents

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