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Mf-1000/1100-Hcbt

by Med -Fibers Inc.

Ref MF-1000/1100-HCBT

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00865325000155 Basic UDI-DI 00865325000155UDI-DIDate5 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00865325000155 UDI-DI Date7 Sep 2016ListedStatusListed 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 22 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  • Withdrawn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
MED-Fibers, Inc. EUDAMED
Mf-1000/1100-Hcbt GUDID
Generic Name
General/multiple surgical laser system beam guide, reusable
Model / Ref / Catalog
MF-1000/1100-HCBT, MF-1000/1100-DR
Primary DI / UDI-DI
00865325000155
Basic UDI-DI
B-00865325000155
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011003 Holmium surgical laser
GMDN Term
General/multiple surgical laser system beam guide, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K124003)

Other devices from Med -Fibers Inc.

See all devices from Med -Fibers Inc. →

Properties

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

Other properties (16)

  • 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