FDA.reportPublic FDA data

NED-DP Nano Eye Device for Digital Pathology

Primary DI
08052691050002
Brand
NED-DP Nano Eye Device for Digital Pathology
Company
NTP NANO TECH PROJECTS SRL
Model
PF0001
Catalog number
PF0001
Device description
Digital Microscope for Digital Pathology
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IBJLight, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052691050002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052691050002080526910500028052691050002

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide digital imaging scanner IVDA mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
339900220
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052691050019NED-DH Nano Eye Device for Digital HematologyPF0002PF00022024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664816005866LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005873LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005934LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005941LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005958LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005965LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
08052691050019NED-DH Nano Eye Device for Digital HematologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
GYNXMI60000GynexGYNEX CORPORATIONIBJ2023-12-20
04260158450065FotoFinder medicamFotoFinder Systems GmbHIBJ2023-08-07
04260158450089FotoFinder leviacamFotoFinder Systems GmbHIBJ2023-08-07
00664816002391LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002407LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002414LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002421LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002759LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00852728008864SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860009669192SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860010027707SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00850147000094MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
85014700009486MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
00304040043400Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043417Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043424Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043431Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043448Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00664816000908LW Scientific, IncLW SCIENTIFIC, INC.IBJ2021-04-09
00664816000922LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000939LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000946LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000953LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09