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Fraxis Set Package FRX-C1

by CLASSYS Inc.

Ref FRAXIS

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016903959 Basic UDI-DI 08800016903959UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016903959 UDI-DI Date30 Oct 2024ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Fraxis EUDAMED
Fraxis Set Package GUDID
Generic Name
Dermatological carbon dioxide laser system
Device Name
CO2 laser system
Model / Reference
FRAXIS EUDAMED
FRX-C1 GUDID
Primary DI / UDI-DI
08800016903959
Basic UDI-DI
B-08800016903959
510(k) Number
FDA Product Code
GEX, 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FRAXIS
GUDID
FRX-C1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K172096)

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No
  • Expiration Date: No