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Device Explorer · FDA GUDID · GMDN 44914

Optical anoscope, single-use

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 devices99in commercial distribution
Companies9labelers on GUDID
Single‑use90%of device records
Sterile32%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Thd Spa6263%
Sapi Med Spa1313%
Welch Allyn, Inc.1010%
Coopersurgical, Inc.44%
Bioseal33%
Obp Corporation33%
Haemoband Surgical22%
Heine Optotechnik Gmbh & Co. Kg11%

Top labelers

CompanyDevicesShare
Thd Spa6263%
Sapi Med Spa1313%
Welch Allyn, Inc.1010%
Coopersurgical, Inc.44%
Bioseal33%
Obp Corporation33%
Haemoband Surgical22%
Heine Optotechnik Gmbh & Co. Kg11%
Omec Medical (Nv) Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SleeveLUX 16 Anoscope/ProctoscopeSleeveLUX 24 Anoscope/ProctoscopeHEINE UniSpec® Disposable TubesAnoSPECThermora AnoscopeWelch Allyn, Inc.Bioseal Inc.Sani-ScopeANOSPECTHD N-ano anoscopeTHD N-Ano AnoscopeTHD N-Ano anoscopeTHD N-Ano anoscopesTHD disposable sterile and not sterie Ano-, ProcSelf-light anoscopesEpoflier

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

FDA product codes

CodeNameDevices
FERAnoscope And Accessories84
GCPEndoscope, Ac-Powered And Accessories62
FERAnoscope and accessories12
KDCINSTRUMENT, SURGICAL, DISPOSABLE3
FFQSpeculum, Rectal1
FAMsigmoidoscope and accessories, flexible/rigid1

GMDN & GCC registration

  • GMDN code 44914 · non‑implantable
  • Single‑use 90% · sterile 32% · Rx‑only 87% · 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

Outer Diameter (Millimeter) · 62Length (Millimeter) · 62

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

How many optical anoscope, single-use products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical anoscope, single-use", from 9 companies. The largest labeler is Thd Spa with 63% of records.

Which FDA product codes apply?

FER (Anoscope And Accessories), GCP (Endoscope, Ac-Powered And Accessories), FER (Anoscope and accessories), KDC (INSTRUMENT, SURGICAL, DISPOSABLE)

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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