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iSR'obot Mona Lisa 2.0

by Biobot Surgical Pte Ltd United States EUDAMED

Ref iSR'obot Floor Stand Stabilizer EMDN Z12169099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number888501461iSRobot25 Basic UDI-DIDate3 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
iSR'obot Mona Lisa 2.0
Model / Reference
iSR'obot Floor Stand Stabilizer
Primary DI / UDI-DI
08885014610429
Basic UDI-DI
888501461iSRobot25
EMDN Code
Z12169099 Various instruments for urology - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
SG-MF-000020631
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biobot Surgical Pte. Ltd.

See all devices from Biobot Surgical Pte. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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

Sources (1)

  • EUDAMED 71aacb05-a3d3-4142-8efc-9bad92a9c618 61 fields · synced 24 Oct 2026