FDA.reportPublic FDA data

Refraction Unit

Primary DI
05907642694596
Brand
Refraction Unit
Company
MDT SP Z O O
Model
TRU-2000
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMFStand, Instrument, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05907642694596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05907642694596059076426945965907642694596

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination stationA mains electricity (AC-powered) device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician. It consists of a chair to position the patient in a seated or reclined posture for easy access and comfort, a stand designed as a column or post used to provide support and position control for devices commonly used during an ophthalmic examination, and a table designed as a work surface to support ophthalmic instruments. It has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient to facilitate examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
366126408
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
05907642694602Ophthalmic Operator's ChairOC-12025-07-16
05907642694435Refraction UnitTOROS2025-08-08
05907642694008Ophthalmic StoolT-L2025-07-16
05907642694015Ophthalmic StoolT-P2025-07-16
05907642694022Ophthalmic StoolT-S2025-07-16
05907642694039Ophthalmic StoolT-LT2025-07-16
05907642694169Ophthalmic Electric TableTTUD-10002025-07-16
05907642694176Ophthalmic Electric TableCOMBO-12025-07-16
05907642694183Ophthalmic Electric TableRT S2025-07-16
05907642694190Ophthalmic Electric TableTT-40602025-07-16
05907642694206Ophthalmic Electric TableMD-22025-07-16
05907642694213Ophthalmic Electric TableTTH-10002025-07-16
05907642694220Ophthalmic Electric TableRT VF2025-07-16
05907642694237Ophthalmic Electric TableCOMBO-22025-07-16
05907642694268Ophthalmic Electric TableRT B2025-07-16
05907642694275Ophthalmic Electric TableMD-V2025-07-16
05907642694282Ophthalmic Electric TableTT-10602025-07-16
05907642694299Ophthalmic Electric TableRT V2025-07-16
05907642694305Ophthalmic Electric TableTTVS-10002025-07-16
05907642694312Ophthalmic Electric TableMD-3V2025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190015TOPCONANTONI CARLES SAHMF2026-06-01
00850020301638RelianceHAAG-STREIT USA, INC.HMF2026-05-29
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428616IS-5500TOPCON HEALTHCARE INCHMF2024-05-28
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17
00850053428524IS-6500TOPCON HEALTHCARE INCHMF2024-05-17