FDA.reportPublic FDA data

YEASN

Primary DI
06971922134064
Brand
YEASN
Company
Chongqing Yeasn Science & Technology Co.,Ltd.
Model
HX-400
Catalog number
HX4/9
Published
2022-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLHPupillometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLHPupillometer, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971922134064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971922134064069719221340646971922134064

GMDN Terms#

Term, Definition table
TermDefinition
OphthalmodiastimeterAn ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547954649
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971922132299YEASNYPA-2100S2026-05-01
06971922133319YEASNYPB-2100P2026-05-01
06971922136334YEASNYPC-100K2026-04-25
06971922132770YEASNSLY-1002025-04-08
06971922132558YEASNMPH150MPH1502024-11-30
06971922132787YEASNMPH150MPH150BN2024-11-30
06971922132794YEASNMPH150MPH150BP2024-11-30
06971922136037YEASNYPC-1002024-08-21
06971922131070YEASNCCQ-800CCQ8/102022-04-21
06971922132725YEASNSLY-100SLY1/392022-04-21
06971922133029YEASNYPB-2100YPB21/12022-04-21
06971922131377YEASNCCQ1100CCQ11/22022-03-05
06971922132046Digital RefractorYPA-2100YPA21/32021-11-29
06971922130097FocimeterCCQ-4002021-03-03
06971922130103FocimeterCCQ-5002021-03-03
06971922130110Auto FocimeterCCQ-11002021-03-03
06971922130042Auto FocimeterCCQ-8002020-10-22
06971922130066LCD Visual ChartYPB-21002020-10-22
06971922130073Digital RefractorYPA-21002020-10-22
06971922130080PupilometerHX-4002020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628308210534LombartINNOVA Medical Ophthalmics IncHLH2026-03-31
00628308210541S4OptikINNOVA Medical Ophthalmics IncHLH2026-03-31
00628308210558PD-1INNOVA Medical Ophthalmics IncHLH2026-03-31
00812559010580PDM Digital PD MeterREICHERT, INC.HLH2025-08-12
00860014277511Advancing EyecareLombart Brothers, Inc.HLH2025-07-28
06971922134026YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-03-21
06971922130080PupilometerChongqing Yeasn Science & Technology Co.,Ltd.HLH2020-10-22