UE BRONCHO Single-Use Bronchoscopes

Primary DI
16937048207904
Brand
UE BRONCHO Single-Use Bronchoscopes
Company
Zhejiang UE Medical Corp
Model
EBS-500C
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
OTC
false
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
16937048207904PackageGS15In Commercial Distribution
26937048207901PackageGS110In Commercial Distribution
06937048207907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693704820790416937048207904
2693704820790126937048207901
06937048207907069370482079076937048207907

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542992969
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06937048207914UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06937048207884UE DisplayUE-M10S2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
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

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