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Device Explorer · FDA GUDID · GMDN 60353

General physical examination set

A collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurem

US‑registered devices62in commercial distribution
Companies8labelers on GUDID
Single‑use6%of device records
Sterile2%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Heine Optotechnik Gmbh & Co. Kg2642%
Sontec Instruments, Inc.1524%
Bv Medical1118%
U.S. Ophthalmic, L.L.C.58%
Medline Industries, Inc.23%
C F M Technologies Inc12%
Bound Tree Medical, Llc12%
Bioseal12%

Top labelers

CompanyDevicesShare
Heine Optotechnik Gmbh & Co. Kg2642%
Sontec Instruments, Inc.1524%
Bv Medical1118%
U.S. Ophthalmic, L.L.C.58%
Medline Industries, Inc.23%
C F M Technologies Inc12%
Bound Tree Medical, Llc12%
Bioseal12%

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

Brand names on the register (sample)

HEINE® EN 200 Diagnostic CentreHEINE® EN 200 Wall TransformerHEINE XHL® Xenon Halogen BulbsHEINE BETA® 4 Rechargeable HandleHEINE BETA® 400 LED OtoscopeHEINE BETA® 200 LED OtoscopeHEINE BETA® 400 F.O. OtoscopeHEINE BETA® 200 F.O. OtoscopeHEINE K180® F.O. OtoscopeHEINE BETA® 400 Diagnostic SetHEINE BETA® 200 Diagnostic SetHEINE K180® Diagnostic SetHEINE EN 200® Diagnostic CenterHEINE EN 100® Diagnostic CenterEli EzerENT Pocket Light

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

FDA product codes

CodeNameDevices
ERAOtoscope22
HLJOphthalmoscope, Battery-Powered20
ETFUNIT, EXAMINING/TREATMENT, ENT15
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE2
LROGeneral surgery tray2
DXQBlood Pressure Cuff1

GMDN & GCC registration

  • GMDN code 60353 · non‑implantable
  • Single‑use 6% · sterile 2% · Rx‑only 26% · OTC 5%
  • 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) · 1Length (Inch) · 1Height (Inch) · 1

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

How many general physical examination set products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General physical examination set", from 8 companies. The largest labeler is Heine Optotechnik Gmbh & Co. Kg with 42% of records.

Which FDA product codes apply?

ERA (Otoscope), HLJ (Ophthalmoscope, Battery-Powered), ETF (UNIT, EXAMINING/TREATMENT, ENT), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE)

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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