FDA.reportPublic FDA data

zumax

Primary DI
06945095543930
Brand
zumax
Company
Zumax Medical Co., LTD
Model
SR24B
Catalog number
418E1112
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKMRetinoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095543930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095543930069450955439306945095543930

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
06945095543855zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544074zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544159zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544210zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544302zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544470zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544524zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544531zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544562zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544579zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544814zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544852zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544876zumaxZumax Medical Co., LTDHKM2026-05-21
06945095543749zumaxZumax Medical Co., LTDHKM2026-05-18
04053755119967BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
04053755202508BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HKM2023-08-17
04053755193202BETA 200 RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
04053755193219BETA 200 RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
04053755191673BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
00732094098914Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
00732094098952Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
04045396010819ri-scope® retinoscope head slit XL 3.5 VRudolf Riester GmbHHKM2021-01-28
04045396129931ri-scope® retinoscope head slit XL 3.5 V,Rudolf Riester GmbHHKM2021-01-28
04045396140974ri-vision with retinoscope slit XL 3.5 V, C-handleRudolf Riester GmbHHKM2021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
04045396182660ri-vision with slit retinoscope XL/LED 3,5V/120V,Rudolf Riester GmbHHKM2021-01-28
04045396182783ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
00732094087703Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087765Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16