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FreeHand 2.1 Panorama

by MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Ref 52400021Model Robotic camera controller for laparoscopy

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, self-declared

Class I: no certifier involved

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 Number383008873ROBOTSYSTEMS01VH Basic UDI-DI 03830088730035UDI-DIDate3 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Robotic camera controller for laparoscopy, 52400021
Primary DI / UDI-DI
03830088730035
Basic UDI-DI
383008873ROBOTSYSTEMS01VH
EMDN Code
Z1202018001 Robotic arms for videoendoscopy
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
SI-MF-000048191

Other devices from MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Properties

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