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eCO2 DENTA_220V

by Cynosure Lutronic Technology Corporation

Ref Laser System main body (Including Handpiece)Model eCO2 DENTA

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88002918210409BJ3 Basic UDI-DI 08800291821801UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800291821801 UDI-DI Date25 Jun 2026ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Laser System main body (Including Handpiece) EUDAMED
eCO2 DENTA GUDID
Generic Name
Dermatological carbon dioxide laser system
Device Name
Surgical CO2 Laser (RF Type)
Model / Reference
eCO2 DENTA EUDAMED
Laser System main body (Including Handpiece) EUDAMED
eCO2 DENTA_220V GUDID
Primary DI / UDI-DI
08800291821801
Basic UDI-DI
88002918210409BJ3
FDA Product Code
ONG
EMDN Code
Z12011005 Carbon dioxide surgical laser
GMDN Term
Dermatological carbon dioxide laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
eCO2 DENTA
Laser System main body (Including Handpiece)
GUDID
eCO2 DENTA_220V
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Cynosure Lutronic Technology Corporation

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Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No