FDA.reportPublic FDA data

zumax

Primary DI
06945095544333
Brand
zumax
Company
Zumax Medical Co., LTD
Model
SR24F
Catalog number
418-2002
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKLRetinoscope, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544333069450955443336945095544333

GMDN Terms#

Term, Definition table
TermDefinition
Retinoscope, line-poweredA mains electricity (AC-powered), hand-held, ophthalmic device that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The current power is run through a transformer for reduction to low-voltage. Also known as a skiascope and the method as sciascopy.

Regulatory Flags#

DUNS number
421348837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095543787zumaxGL6050475-18102026-05-21
06945095543794zumax10-002110-00212026-05-21
06945095543800zumaxOT8G461E30002026-05-21
06945095543855zumaxSR24B418E18122026-05-21
06945095543909zumaxOT8V468-11102026-05-21
06945095543930zumaxSR24B418E11122026-05-21
06945095543954zumaxEL7010701E30002026-05-21
06945095543978zumaxOT8D461-58132026-05-21
06945095544050zumaxGL6030473-18102026-05-21
06945095544067zumax11-1000801100011000-002026-05-21
06945095544074zumaxSR24B418E51122026-05-21
06945095544098zumax10-001710-00172026-05-21
06945095544111zumaxOT8D461-11102026-05-21
06945095544142zumaxOT8C460-00102026-05-21
06945095544159zumaxSR24B418E58122026-05-21
06945095544173zumaxOT8D461E48102026-05-21
06945095544180zumaxOT8K462-18102026-05-21
06945095544210zumaxSR24A418-48122026-05-21
06945095544296zumaxBM800401E10202026-05-21
06945095544302zumaxSR24A418-18122026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095540342zumaxZumax Medical Co., LTDHKL2026-05-20
06945095543923zumaxZumax Medical Co., LTDHKL2026-05-20
00812559012249OptochekPlusREICHERT, INC.HKL2025-08-12
050552727199263.6V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2020-02-27
050552727199333.6V SPECIALIST OPHTH IN CASEKEELER LIMITEDHKL2020-02-27
050552727199403.6V PROFESSIONAL STREAK RETINOSCOPE IN CASEKEELER LIMITEDHKL2020-02-27
050552727199573.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASEKEELER LIMITEDHKL2020-02-27
05055272719964US PROFESSIONAL LED STUDENT KIT-SLIMKEELER LIMITEDHKL2020-02-27
05055272719971US PROFESSIONAL COMPLETE LED STUDENT SETKEELER LIMITEDHKL2020-02-27
050552727199883.6V PRACTITIONER/ FIBRE-OPTIC DIAGNOSTIC SETKEELER LIMITEDHKL2020-02-27
05055272719995SLIMLINE RECHARGEABLE HANDLE & BATTERYKEELER LIMITEDHKL2020-02-27
05055272720007RECHARGEABLE HANDLE & REFRACTION STAND ADAPTORKEELER LIMITEDHKL2020-02-27
05055272720038US LED SPECIALIST/ RETINOSCOPE STUDENT SETKEELER LIMITEDHKL2020-02-27
06945095531203zumaxZumax Medical Co., LTDHKL2018-07-31
06945095531302zumaxZumax Medical Co., LTDHKL2018-05-24
050552727007712.8V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727007883.6V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727008942.8V SPECIALIST OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727009003.6V SPECIALIST OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727015633.6V PROF STREAK RET HEAD ONLYKEELER LIMITEDHKL2016-08-26
050552727015702.8V PROFESSIONAL SPOT RET & CASEKEELER LIMITEDHKL2016-08-26
050552727015873.6V PROFESSIONAL SPOT RET & CASEKEELER LIMITEDHKL2016-08-26
050552727015942.8V PROFESSIONAL STREAK RET & CASEKEELER LIMITEDHKL2016-08-26
050552727016003.6V PROFESSIONAL STREAK RET & CASEKEELER LIMITEDHKL2016-08-26
05055272701662US PROF STUDENT KIT (SLIM HANDLE)KEELER LIMITEDHKL2016-08-26
050552727016792.8V STREAK RET & PROF OPHTHKEELER LIMITEDHKL2016-08-26
050552727016863.6V STREAK RET & PROF OPHTHKEELER LIMITEDHKL2016-08-26
050552727017162.8V STREAK RET & SPECIALIST OPHTHKEELER LIMITEDHKL2016-08-26
050552727017302.8V SPOT RET & SPECIALIST OPHTHKEELER LIMITEDHKL2016-08-26
050552727128733.6V PROFESSIONAL STREAK LED HEADKEELER LIMITEDHKL2016-08-26