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Bare Fiber HB R 2.1 272 2874

by Asclepion Laser Technologies GmbH

Ref 2874

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

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04058784001320 Basic UDI-DI 04058784001320UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04058784001320 UDI-DI Date6 Aug 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Bare Fiber HB R 2.1 272
Generic Name
General/multiple surgical laser system beam guide, reusable
Model / Reference
2874
Primary DI / UDI-DI
04058784001320
Basic UDI-DI
B-04058784001320
FDA Product Code
GEX
EMDN Code
Z12011085 Laser surgery instruments - consumables
GMDN Term
General/multiple surgical laser system beam guide, reusable
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 · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Asclepion Laser Technologies GmbH

See all devices from Asclepion Laser Technologies GmbH →

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No