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Roller Tip BOX

by Cynosure Lutronic Technology Corporation

Ref Roller Tip BOXModel Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D

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 Number88002918210409aKP Basic UDI-DI 08800291821375UDI-DIDate2 Jul 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  • Withdrawn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

Device Name
eCO2 3D Accessories
Model / Reference
Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D, Roller Tip BOX
Primary DI / UDI-DI
08800291821375
Basic UDI-DI
88002918210409aKP
EMDN Code
Z12011080 Laser surgery instruments - hardware accessories
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000047499
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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