FDA.reportPublic FDA data

Electric table HE Spectralis BR 110-230V

Primary DI
05904815700467
Brand
Electric table HE Spectralis BR 110-230V
Company
CX ENGINEERING SP Z O O
Model
2
Catalog number
HE_S_BR_2
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05904815700467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904815700467059048157004675904815700467

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic instrument table, line-poweredA 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.

Regulatory Flags#

DUNS number
850896321
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05904815700160VISUCORE 500 Table3772302032023-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628308210435S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
00628308210459S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
04260647940022Sliding keyboard shelfAKRUS GmbH & Co. KGHRJ2025-11-28
04260647940039Footrest extensionAKRUS GmbH & Co. KGHRJ2025-11-28
00628308210336S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210343S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210350S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210367S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00850003069616AIT-250WTOPCON HEALTHCARE INCHRJ2025-07-17
05907642694169Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694176Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694183Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694190Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694206Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694213Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694220Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694237Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694268Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694275Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694282Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694299Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694305Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694312Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694329Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694336Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694343Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694350Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
00628308210305S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04
00628308210312S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04
00628308210329S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04