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Dentálny implantát MI

by MARTIKAN s.r.o. 18 variants

Ref MI 2,0-12-2Model MI

Expiring European Union

CE MDR

Valid until

20 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2022-MDR/QS-003/A Date10 Apr 2026IssuedStatusExpiring expires 20 Jul 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-003/A Expiring Supplemented Expires in 262 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Apr 2026
    Expires
    20 Jul 2027
    Reason
    Other
  • 2022-MDR/TD-003/A Expiring Supplemented Expires in 262 days

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Apr 2026
    Expires
    20 Jul 2027
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Dentálny implantát
Model / Reference
MI, MI 2, 0-12-2
Primary DI / UDI-DI
08586023522108
Basic UDI-DI
858602352MIY7
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000005834

Other devices from MARTIKAN s.r.o.

See all devices from MARTIKAN s.r.o. →

Properties

  • Implantable

Other properties (13)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No