FDA.reportPublic FDA data

UE BRONCHO Single-Use Bronchoscopes

Primary DI
06937048207914
Brand
UE BRONCHO Single-Use Bronchoscopes
Company
Zhejiang UE Medical Corp
Model
EBS-600C
Device description
The UE BRONCHO Single-Use Bronchoscopes is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. The endoscope is intended to provide visualization via UE Medical displaying unit.
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251823000UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)Zhejiang UE Medical Corp.2025-08-11EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16937048207911PackageGS15In Commercial Distribution
26937048207918PackageGS110In Commercial Distribution
06937048207914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693704820791116937048207911
2693704820791826937048207918
06937048207914069370482079146937048207914

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Regulatory Flags#

DUNS number
542992969
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937048207891UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
06937048207907UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
06937048207884UE DisplayUE-M10S2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06970283489219UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
06970283489226UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
06970283489233UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
16970283489216UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
16970283489223UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
16970283489230UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
06970283489394UE Intubation StyletP32024-12-17
06970283489400UESCOPE Single-Use Laryngoscope Blade, Size J3J32024-12-17
06970283489424UE Intubation StyletP22024-12-17
06970283489417UE Intubation StyletP12024-12-16
06970283483941UE DisplayVL4602022-09-05
06970283481633UESCOPE Disposable Laryngoscope Blade, Size 2UED-22022-09-09
06970283481664UESCOPE Disposable Laryngoscope Blade, Size 3UED-32022-09-09
06970283481695UESCOPE Disposable Laryngoscope Blade, Size 4UED-42022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01
00850023925206WiScope®Otu Medical Inc.EOQ2023-04-30