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Applanation Tonometer

Primary DI
06973211070671
Brand
Applanation Tonometer
Company
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Model
SK-R
Device description
It is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid the diagnosis of glaucoma
Published
2020-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191314000Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd.2019-12-19HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973211070491PackageGS12In Commercial Distribution
26973211070507PackageGS14In Commercial Distribution
26973211070514PackageGS16In Commercial Distribution
26973211070521PackageGS18In Commercial Distribution
06973211070671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697321107049126973211070491
2697321107050726973211070507
2697321107051426973211070514
2697321107052126973211070521
06973211070671069732110706716973211070671

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, manualAn ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with 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). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.

Regulatory Flags#

DUNS number
545824560
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973211070619Fundus Camera SK-650B2025-08-18
06973211070930Ophthalmic Slit Lamp MicroscopeLS-6C2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeLS-7C2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeLS-7CS2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeLS-7CE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeLS-8A2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeLS-9CS2025-08-18
06973211071500Fundus CameraSK-680B2025-08-18
06973211071517Fundus CameraSK-680C2025-08-18
06973211071623Corneal Topographer SK-7000A2025-08-18
06973211071630Corneal Topographer SK-7000B2025-08-18
06973211071869Kerato refractometerSK-6800A2025-08-18
06973211071876Kerato refractometerSK-6800B2025-08-18
06973211070633Ophthalmic Ultrasound Examination InstrumentSK-3000A2023-01-17
06973211070640Ophthalmic Ultrasound Examination InstrumentSK-2000AP2023-01-17
06973211070701Ophthalmic Ultrasound Examination InstrumentSK-3000B2023-01-17
06973211070718Ophthalmic Ultrasound Examination InstrumentSK-3000C2023-01-17
06973211070749Ophthalmic Ultrasound Examination InstrumentSK-2000A2023-01-17
06973211070756Ophthalmic Ultrasound Examination InstrumentSK-2000P2023-01-17
06973211070916Sunkingdom RetinometerSK-6500A2023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06430033852415iCare IC100ICARE FINLAND OYHKY2025-12-04
06430033852514iCare IC200ICARE FINLAND OYHKY2025-12-04
00812559012485" Ocu-Film® +"""REICHERT, INC.HKY2025-08-15
00812559012492"Ocu-Film® +"""REICHERT, INC.HKY2025-08-14
00812559012454Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, RechargeableREICHERT, INC.HKY2025-08-12
00812559011945Tono-Vera® Tonometer Starter Kit, AA BatteryREICHERT, INC.HKY2025-08-12
00812559012324Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00757770407309Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770408856Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770417629Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770420803Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770426867Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
06430033851784ST500 SmartCradleICARE FINLAND OYHKY2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKY2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKY2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKY2024-11-07
00887482112366Symmetry Allen-SchiotzASPEN SURGICAL PRODUCTS, INC.HKY2024-08-20
06430033851098iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851104iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851463iCare IC200ICARE FINLAND OYHKY2023-06-20
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKY2023-06-12
04560323648564TAKAGITAKAGI SEIKO CO.,LTD.HKY2023-06-09
03664188000138LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860000603805Automated Ophthalmics Softips AUTOMATED OPHTHALMICS, INC.HKY2022-11-17
00860412001541CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12