FDA.reportPublic FDA data

zumax

Primary DI
06945095544135
Brand
zumax
Company
Zumax Medical Co., LTD
Model
DM6F
Catalog number
410-2000
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
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544135069450955441356945095544135

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
06945095528869zumaxOMS2050825205050741-0E2026-10-09
06945095528906zumaxCLS3050 Pro826200050720-002026-10-09
06945095528920zumaxOMS3500820111-10141-0002026-10-09
06945095528937zumaxOMS1950820110-10259-0002026-10-09
06945095528944zumaxOMS3500 Max820111-10142-0002026-10-10
06945095528951zumaxOMS3500 Max820111-10143-0002026-10-10
06945095528968zumaxOMS3000 Pro820110-10263-00B2026-10-10
06945095535904zumaxOMS2650820114-10129-0382026-10-10
06945095535928zumaxOMS2650820114-10130-0002026-10-10
06945095556701zumaxSLT850T013042BN-0B2026-10-09
06945095556718zumaxSLT50T-25502026-10-09
06945095557005zumaxSLD50D-25422026-10-09
06945095557012zumaxSLD50D-25502026-10-09
06945095557029zumaxSLT50M-30342026-10-09
06945095528975zumaxOMS2680820112-10105-0002026-09-29
06945095528982zumaxOMS6000820110-10266-00E2026-09-29
06945095528999zumaxCLS3080830600050020-002026-09-29
06945095529002zumaxOMS3500820111-10146-0002026-09-29
06945095557067zumaxDFK air850PA5GY5000-312026-09-29
06945095557074zumaxDFK air850PA5BU4000-312026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181711OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
00732094346930Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346947Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346954Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346961Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094347555Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346978Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346985Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346992Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347005Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347012Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347029Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347036Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05