zumax

Primary DI
06945095544166
Brand
zumax
Company
Zumax Medical Co., LTD
Model
DM6DE
Catalog number
410E1811
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
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544166069450955441666945095544166

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscopeAn electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.

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
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
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00634782089238Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
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00634782089320Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782088910Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088934Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088941Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088958Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088965Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088972Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088989Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088996Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12