Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Endoscope sheath, single-use
Device Explorer · FDA GUDID · GMDN 63564

Endoscope sheath, single-use

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a p

US‑registered devices208in commercial distribution
Companies10labelers on GUDID
Single‑use99%of device records
Sterile88%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Well Lead Medical Co.,Ltd16881%
Verathon Medical (Canada) Ulc126%
Proact Medical Limited115%
Surgease Innovations Limited42%
Uvision 360, Inc.42%
Meditech Endoscopy Ltd31%
Lsi Solutions, Inc.31%
Virtual Incision Corporation10%

Top labelers

CompanyDevicesShare
Well Lead Medical Co.,Ltd16881%
Verathon Medical (Canada) Ulc126%
Proact Medical Limited115%
Surgease Innovations Limited42%
Uvision 360, Inc.42%
Meditech Endoscopy Ltd31%
Lsi Solutions, Inc.31%
Virtual Incision Corporation10%
Invotec International, Inc.10%
Clarus Medical, Llc10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ClearPetraLarge LumenEye x1 Manifold -30mmLarge LumenEye x1 Manifold -26mmConsumable Pack (Sheath, Obturator & Manifold)Consumable Pack (Sheath, Obturator, Manifold & CProtech XLProtech SProtech LGlideScope®LUMINELLE Dx 360o Rotatable Disposable Sheath (DLUMINELLE DTx 360 Rigid Rotatable Disposable SheUvision HysteroscopeLUMINELLE DTx 360 Rotatable Disposable SheathsMIRAJNW URTRACJNW URTRAC™

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

FDA product codes

CodeNameDevices
FAJCystoscope And Accessories, Flexible/Rigid175
FEDEndoscopic Access Overtube, Gastroenterology-Urology171
FGAKit, Nephroscope171
CCWLaryngoscope, Rigid23
FANSigmoidoscope, Rigid, Electrical4
HIHHysteroscope (And Accessories)4

GMDN & GCC registration

  • GMDN code 63564 · non‑implantable
  • Single‑use 99% · sterile 88% · Rx‑only 92% · 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 endoscope sheath, single-use products are registered in the US?

208 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscope sheath, single-use", from 10 companies. The largest labeler is Well Lead Medical Co.,Ltd with 81% of records.

Which FDA product codes apply?

FAJ (Cystoscope And Accessories, Flexible/Rigid), FED (Endoscopic Access Overtube, Gastroenterology-Urology), FGA (Kit, Nephroscope), CCW (Laryngoscope, Rigid)

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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