FDA.reportPublic FDA data

ScopEYE

Primary DI
08800182600355
Brand
ScopEYE
Company
MediThinQ Co., Ltd.
Model
SE-EDNH
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800182600355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800182600355088001826003558800182600355

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695814118
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800182600041ScopEYESE-TXD2024-02-16
08800182600195ScopEYEGV-200 Smart Glasses2024-02-16
08800182600331ScopEYESE-EDN2024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810004820460Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
00810004820463Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820149Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820705Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
10810004820712Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
10810004820729Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
10810004820736Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
10810004820750Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
00810004820128Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820135Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820142Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820708Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
00810004820715Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
00810004820722Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
00810004820739Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
00810004820753Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
04055207001189NARichard Wolf GmbHFEM2024-08-06
04055207025024RIWOMOBILRichard Wolf GmbHFEM2024-08-06
04051423002085TV-adapterasap endoscopic products GmbHFEM2024-07-11
04055207008928NARichard Wolf GmbHFEM2024-05-21
04055207009086NARichard Wolf GmbHFEM2024-05-21
04055207009116NARichard Wolf GmbHFEM2024-05-21
08800182600041ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600195ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600331ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
06972197480887PylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480894TrolleyHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480900Trolley with pylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31