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Device Explorer · FDA GUDID · GMDN 32721

Ophthalmic tonometer, manual

An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the

US‑registered devices57in commercial distribution
Companies16labelers on GUDID
Single‑use5%of device records
Sterile5%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Haag-Streit Ag1018%
Ocular Instruments, Inc.916%
Ambler Surgical Corp.712%
Bausch & Lomb Incorporated59%
Shanghai Mediworks Precision Instruments Co.,Ltd.47%
Keeler Limited47%
Chongqing Sunkingdom Medical Instrument Co.,Ltd35%
Zien Medical Technologies, Llc35%

Top labelers

CompanyDevicesShare
Haag-Streit Ag1018%
Ocular Instruments, Inc.916%
Ambler Surgical Corp.712%
Bausch & Lomb Incorporated59%
Shanghai Mediworks Precision Instruments Co.,Ltd.47%
Keeler Limited47%
Chongqing Sunkingdom Medical Instrument Co.,Ltd35%
Zien Medical Technologies, Llc35%
U.S. Ophthalmic, L.L.C.35%
Katena Products, Inc.24%
Costruzioni Strumenti Oftalmici C.S.O. Srl24%
Takagi Seiko Co.,Ltd.12%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Applanation TonometerTomeyMediWorksKeeler Disposable Tonomate - BX 100KAT APPLANATION PRISMKAT T-TypeKAT R-TypeTAKAGICATSCATS Tonometer LegacyCATS TonometerEli EzerLuxVisionKATENASCHIOTZ TONOMETERCT210 Contact Tonometer

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

FDA product codes

CodeNameDevices
HKYTonometer, Manual47
HKYTonometer, manual8
HKXTonometer, Ac-Powered3
HTYPIN, FIXATION, SMOOTH1
HKYTONOMETER, MANUAL1

GMDN & GCC registration

  • GMDN code 32721 · non‑implantable
  • Single‑use 5% · sterile 5% · Rx‑only 49% · 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

Width (Inch) · 2Length (Inch) · 2

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

How many ophthalmic tonometer, manual products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic tonometer, manual", from 16 companies. The largest labeler is Haag-Streit Ag with 18% of records.

Which FDA product codes apply?

HKY (Tonometer, Manual), HKY (Tonometer, manual), HKX (Tonometer, Ac-Powered), HTY (PIN, FIXATION, SMOOTH)

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.

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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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