FDA.reportPublic FDA data

YEASN

Primary DI
06971922134026
Brand
YEASN
Company
Chongqing Yeasn Science & Technology Co.,Ltd.
Model
HX-400
Catalog number
HX4/1
Published
2022-03-21
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
06971922134026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971922134026069719221340266971922134026

GMDN Terms#

Term, Definition table
TermDefinition
Pupillometer, manualA manually-operated ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. Evaluation of the pupil is done by manually assessing the size of the pupil to parameters on this device, e.g., holes or scaled measurements.

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
06971922134064YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-04-21
06971922130080PupilometerChongqing Yeasn Science & Technology Co.,Ltd.HLH2020-10-22