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Bare Fiber

by CeramOptec GmbH 6 variants

Ref 503200155

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404905902N2 Basic UDI-DI 04049059519374UDI-DIDate1 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04049059519374 UDI-DI Date25 Sep 2025ListedStatusListed 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 24 Oct 2026.

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  • Withdrawn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
CeramOptec
Generic Name
General/multiple surgical solid-state laser system
Device Name
Bare Fiber
Bare Fiber, reusable, sterile
Model / Ref / Catalog
503200155, Leonardo® Duster Fiber 272um Reusable, IC
Primary DI / UDI-DI
04049059519374
Basic UDI-DI
404905902N2, 404905922N8
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011099 Laser surgery instruments - other
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
503200155
GUDID
Leonardo® Duster Fiber 272um Reusable, IC
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
DE-MF-000005607

Other devices from CeramOptec GmbH

See all devices from CeramOptec GmbH →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

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