FDA.reportPublic FDA data

INAMI

Primary DI
04547451026709
Brand
INAMI
Company
INAMI & CO., LTD.
Model
L-5130
Device description
L-5130 Applanation Tonometer
Published
2023-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKXTonometer, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547451026709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547451026709045474510267094547451026709

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, line-poweredAn ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690688742
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547451339212INAMI25R-0000822026-01-29
04547451338338INAMIKDM-42025-12-19
04547451328650INAMIKDM-32023-07-27
04547451339045Inami25R-0000692025-12-05
04547451338062Inami Ophthalmic InstrumentsM-2225S2024-10-07
00454745102558INAMIL-05442025-11-12
04547451081777INAMIL-05412025-11-12
04547451338321INAMIL-03002025-08-29
04547451043744Inami Ophthalmic InstrumentsS-3252025-08-06
04547451338628Inami Ophthalmic InstrumentsM-2221S2025-06-19
04547451338635Inami Ophthalmic InstrumentsM-2221L2025-06-19
04547451338642Inami Ophthalmic InstrumentsM-2221R2025-06-19
04547451336808Inami Ophthalmic InstrumentsM-22252025-06-13
04547451333883Inami Ophthalmic InstrumentsK-0391T2025-05-28
04547451336815Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451337560Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451026273INAMIL-2510B2025-03-06
04547451026280INAMIL-2510HB2025-03-06
04547451336792Inami Ophthalmic InstrumentsS-892024-10-08
04547451337904Inami Ophthalmic InstrumentsS-942024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
04719876420046TonoVueCRYSTALVUE MEDICAL CORPORATIONHKX2026-04-15
06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
06430033851784ST500 SmartCradleICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKX2024-11-07
00851158007683Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2024-01-25
04547451026686INAMI INAMI & CO., LTD.HKX2023-07-27
03615020000458WAVE ANALYZER MEDICA 800ESSILOR INTERNATIONALHKX2023-07-25
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKX2023-06-12
08800019600435Non-contact Tonometer HNT-1PHuvitz Co., Ltd.HKX2023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHuvitz Co., Ltd.HKX2023-06-12
03664188000145Visionix VX650LUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
04047844051269DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04047844051276DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04582273600263NON-CONTACT TONOMETERTOMEY CORPORATION.HKX2022-04-01
00851158007706Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2021-01-04
M6333974340JEDMEDJEDMED INSTRUMENT COMPANYHKX2020-09-01
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25