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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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Medeia Group Ltd

Certificate 20M00006CRT01

Withdrawn
Valid until
Feb 6, 2030

Certificate 20M00006CRT01, a Quality management system issued to Medeia Group Ltd, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number
20M00006CRT01
Certificate type
Quality management system
Certificate status
Withdrawn
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
4
Certificate ID
191220M00006CRT01

Validity

Issued
Feb 6, 2025
Valid from
Feb 6, 2025
Valid until
Feb 6, 2030

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
—
QMS/MOS type
Others

History

Status changes

  • Withdrawn

Supersedes

  • 20M00006CRT01Quality management systemReinstatedFeb 6, 2025 → Feb 6, 2030

Scope coverage

Class IIa2

2 scopes

  • MDA 0204
    Class IIa
  • VitalScan ANS (HW10)
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Medeia Group Ltd
Manufacturer SRN
BG-MF-000025710
Manufacturer country
Bulgaria