FDA.reportPublic FDA data

Ophthalmic Unit

Primary DI
06971821406064
Brand
Ophthalmic Unit
Company
Ningbo Ming Sing Optical R & D Co., Ltd.
Model
TCS-900
Device description
A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRJTable, Instrument, Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRJTable, Instrument, Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971821406064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971821406064069718214060646971821406064

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic instrument table, manualA device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It may have manual height adjustments enabling the clinician to raise/lower the surface to align the instruments to the patient's eye level.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057487305541webmaster@nbmingsing.com

Regulatory Flags#

DUNS number
654386890
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971821408006AUTO LENSMETERTL-65002019-12-02
06971821408020AUTO LENSMETERTL-68002019-12-02
06971821402073AUTO REF/KERATOMETERRM-96002022-01-19
06971821402127AUTO REF/KERATOMETERARK-9102021-11-03
06971821405012LCD Chart monitorCM-22002021-07-30
06971821406057Ophthalmic unitTCS-8802021-07-30
06971821402004AUTO REF/KERATOMETERKR-90002021-06-22
06971821402080AUTO REF/KERATOMETERKR-98002021-06-22
06971821401038Computerized vision testerCV-78002020-08-20
06971821401021COMPUTERIZED VISION TESTERCV-76002019-12-02
06971821402011AUTO REF/KERATOMETERRM-90002019-12-02
06971821402066AUTO REF/KERATOMETERKR-96002019-12-02
06971821406040Ophthalmic unitTCS-8202020-08-31
06971821404015Auto chart projectorACP-15002020-08-05
06971821403001LCD CHART MONITORCM-1900C2019-12-02

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Primary DI, Brand, Company table
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00628308210305S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04
00628308210312S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04