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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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MD Atlas
Documents

Mikai s.p.a.

Certificate ITH 1343576 1

Rev. 1.0Issued

Valid until: Jan 23, 2030

Overview

Certificate number: ITH 1343576 1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1936ITH 1343576 11.0

Validity

Issued: Jan 24, 2025
Valid from: Jan 24, 2025
Valid until: Jan 23, 2030

Manufacturer

Manufacturer: Mikai s.p.a.
Manufacturer SRN: IT-MF-000030732
Manufacturer country: Italy

Notified body

Notified body: TUV Rheinland Italia SRL
Notified body SRN: 1936
Notified body country: Italy

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: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIb1

2 scopes

Dispositivi non impiantabili non attivi per ortopedia e riabilitazione Non-active non-implantable orthopaedic and rehabilitation devices
Class I
Impianti ossei e ortopedici non attivi Non-active osteo- and orthopaedic implants
Class IIb

Documents

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