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SS FiberLase GYN LAP-S

by Transamerican Technologies International

Ref AC-2059630

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 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/MDR EUDAMED Number0860009714905UM Basic UDI-DI 00860009714946UDI-DIDate26 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860009714946 UDI-DI Date20 Jun 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SS FiberLase GYN LAP-S EUDAMED
FiberLase GUDID
Generic Name
General/multiple surgical laser system beam guide, reusable
Device Name
FiberLase Fiber Optic Handpieces
Model / Reference
AC-2059630
Primary DI / UDI-DI
00860009714946
Basic UDI-DI
0860009714905UM
Direct Marketing DI
00860009714946
510(k) Number
FDA Product Code
GEX
EMDN Code
L030199 General surgery surgical cannulas and handpieces, reusable - other
GMDN Term
General/multiple surgical laser system beam guide, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007955
Authorised representative
QNET B.V. NL-AR-000002695

Other devices from Transamerican Technologies International

See all devices from Transamerican Technologies International →

Properties

  • Reusable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No