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Mako

by MAKO Surgical Corp. 21 variants

Ref 700002190743-03Model 08858251002272SM

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251002272SM Basic UDI-DI 07613327629132UDI-DIDate20 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
TD-04 - MAKO - Class IIa - Software Discs
Model / Reference
08858251002272SM, 700002190743-03
Primary DI / UDI-DI
07613327629132
Basic UDI-DI
08858251002272SM
Direct Marketing DI
07613327629132
EMDN Code
Z12130482 Stereotactic orthopaedic surgery instruments - software accessories
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000000703
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Reusable
  • Measuring Function

Other properties (11)

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