FDA.reportPublic FDA data

Endofresh

Primary DI
06974065750108
Brand
Endofresh
Company
Daichuan Medical (Shenzhen) Co., Ltd
Model
XZING-C200B
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192704000Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.2020-09-02FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974065750105PackageGS112In Commercial Distribution
06974065750108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697406575010516974065750105
06974065750108069740657501086974065750108

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.

Regulatory Flags#

DUNS number
554552270
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974065750078EndofreshXZING-W200B2026-10-21
06974065750191EndofreshXZING-S22026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974065750191EndofreshDaichuan Medical (Shenzhen) Co., LtdFDF2026-10-21
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25