Consulting Wallah › Device Explorer › Other devices › Phacoemulsification system handpiece
Device Explorer · FDA GUDID · GMDN 34900

Phacoemulsification system handpiece

A holder for a dedicated detachable tip that together become a unit that delivers energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus

US‑registered devices67in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.4567%
Alcon Laboratories, Inc.710%
Johnson & Johnson Surgical Vision, Inc.57%
Medical Technical Products, Inc.46%
Bausch & Lomb Incorporated34%
This Ag11%
Carl Zeiss Meditec Ag11%
Oertli-Instrumente Ag11%

Top labelers

CompanyDevicesShare
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.4567%
Alcon Laboratories, Inc.710%
Johnson & Johnson Surgical Vision, Inc.57%
Medical Technical Products, Inc.46%
Bausch & Lomb Incorporated34%
This Ag11%
Carl Zeiss Meditec Ag11%
Oertli-Instrumente Ag11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VERITAS SWIVEL PHACO HANDPIECE SYSTEMELLIPS FX PHACO HANDPIECEELLIPS PHACOSOVEREIGN PHACO HANDPIECE SYSTEMWHITESTAR PHACO HANDPIECEPhaco Handpiece Sophi ECOULITE PHACO HANDPIECEUS Handpiece, VizualUS Handpiece, MiniUS Handpiece, Standard, MedaUS Handpiece, StandardBausch + LombMillenniumCENTURION®Centurion, OZilConstellation

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HQCUnit, Phacofragmentation60
HQCUnit, phacofragmentation11
HQEInstrument, vitreous aspiration and cutting, ac-powered5
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2

GMDN & GCC registration

  • GMDN code 34900 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many phacoemulsification system handpiece products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Phacoemulsification system handpiece", from 8 companies. The largest labeler is D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. with 67% of records.

Which FDA product codes apply?

HQC (Unit, Phacofragmentation), HQC (Unit, phacofragmentation), HQE (Instrument, vitreous aspiration and cutting, ac-powered), HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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