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Device Explorer · FDA GUDID · GMDN 10156

Optical anoscope, reusable

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, a

US‑registered devices129in commercial distribution
Companies12labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription57%Rx‑only share
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Share of device records

Elmed Incorporated3225%
Ftt Medical, Inc.3023%
Welch Allyn, Inc.2721%
Avalign Technologies, Inc.97%
Marina Medical Instruments, Inc.86%
Steris Corporation75%
Heine Optotechnik Gmbh & Co. Kg43%
Boss Instruments, Ltd., Inc.43%

Top labelers

CompanyDevicesShare
Elmed Incorporated3225%
Ftt Medical, Inc.3023%
Welch Allyn, Inc.2721%
Avalign Technologies, Inc.97%
Marina Medical Instruments, Inc.86%
Steris Corporation75%
Heine Optotechnik Gmbh & Co. Kg43%
Boss Instruments, Ltd., Inc.43%
Princeton Medical Group, Inc.32%
Teleflex Incorporated32%
A. Schweickhardt Gmbh & Co. Kg11%
Hermann Medizintechnik Gmbh11%

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

Brand names on the register (sample)

SCHWERTHermann Medizintechnik GmbHHEINE® Anoscope Instrument KitHEINE UniSpec® Disposable TubesHEINE® FO Anoscopes with annular FO IlluminationBOSS InstrumentsELMEDMarina MedicalPRINCETONWelch Allyn, Inc.ELMED INCORPORATEDMillenniumMILLENNIUMAvalignESIPILLING

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

FDA product codes

CodeNameDevices
FFQSpeculum, Rectal35
FERAnoscope And Accessories33
FERAnoscope and accessories33
FFQSPECULUM, RECTAL16
MDMInstrument, Manual, Surgical, General Use3
FAMsigmoidoscope and accessories, flexible/rigid2

GMDN & GCC registration

  • GMDN code 10156 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 57% · 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

Length (Centimeter) · 6Length (Inch) · 2

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

How many optical anoscope, reusable products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical anoscope, reusable", from 12 companies. The largest labeler is Elmed Incorporated with 25% of records.

Which FDA product codes apply?

FFQ (Speculum, Rectal), FER (Anoscope And Accessories), FER (Anoscope and accessories), FFQ (SPECULUM, RECTAL)

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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