FDA.reportPublic FDA data

zumax

Primary DI
06945095544449
Brand
zumax
Company
Zumax Medical Co., LTD
Model
HL8200
Catalog number
572-0182
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
EBALight, Surgical Headlight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544449069450955444496945095544449

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

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
08800190600064IHL SeriesILLUCO Co.,Ltd.EBA2026-10-12
06945095556145zumaxZumax Medical Co., LTDEBA2026-07-06
06945095541455zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548157zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548317zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548454zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548515zumaxZumax Medical Co., LTDEBA2026-06-03
06945095546931zumaxZumax Medical Co., LTDEBA2026-06-01
06945095546993zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547037zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547204zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547433zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547440zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547778zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547938zumaxZumax Medical Co., LTDEBA2026-06-01
06945095544258zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544623zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544883zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545019zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545033zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545040zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545057zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545217zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545231zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545521zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545538zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545569zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545729zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545903zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545934zumaxZumax Medical Co., LTDEBA2026-05-20