Skip to content

Accu-Beam Fiber Optic Handpiece - 11ga, 11cm

by Transamerican Technologies International

Ref 9181

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 Number++B177055Y Basic UDI-DI B17791810UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB17791810 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  • Withdrawn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
Accu-Beam Fiber Optic Handpiece - 11ga, 11cm EUDAMED
Accu-Beam GUDID
Generic Name
General/multiple surgical laser system beam guide, reusable
Device Name
Accu-Beam Fiber Optic Handpieces
Model / Reference
9181
Description
Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 11cm, 11ga, ID 2.4mm.
Primary DI / UDI-DI
B17791810
Basic UDI-DI
++B177055Y
Direct Marketing DI
B17791810
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

From the manufacturer

Manufacturer's product page: Fiberoptic Handpieces

Other devices from Transamerican Technologies International

See all devices from Transamerican Technologies International →

Properties

  • Reusable

Other properties (23)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No