FDA.reportPublic FDA data

zumax

Primary DI
06945095546931
Brand
zumax
Company
Zumax Medical Co., LTD
Model
HL8000
Catalog number
555-0010
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06945095546931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095546931069450955469316945095546931

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095546818zumaxSLF50FJ35462026-06-01
06945095546825zumaxSLF50F-30342026-06-01
06945095546832zumaxSLE50E-30342026-06-01
06945095546856zumaxSLF50F-25342026-06-01
06945095546863zumaxSLS50S-30462026-06-01
06945095546887zumaxSLT50M-30422026-06-01
06945095546894zumaxSLH50RU40422026-06-01
06945095546900zumaxSLT50M-60462026-06-01
06945095546948zumaxDFK50P-30452026-06-01
06945095546955zumaxSLF50F-30502026-06-01
06945095546962zumaxSLH50RJ30462026-06-01
06945095546986zumaxSLF50F-25342026-06-01
06945095546993zumaxHL8000556-00822026-06-01
06945095547006zumaxSLT50T-40502026-06-01
06945095547013zumaxSLT50M-25422026-06-01
06945095547020zumaxDFK50P-30002026-06-01
06945095547037zumaxHL8350552-00602026-06-01
06945095547044zumaxSLT50BL25502026-06-01
06945095547051zumaxSLT50BM25422026-06-01
06945095547068zumaxDFT50PT30452026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06945095544449zumaxZumax 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
06945095546054zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546177zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546238zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546535zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546566zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546672zumaxZumax Medical Co., LTDEBA2026-05-20
06945095540205zumaxZumax Medical Co., LTDEBA2026-05-18