FDA.reportPublic FDA data

Amimon

Primary DI
00860014100680
Brand
Amimon
Company
Rocoto Inc.
Model
HM11 Device - MDWL1_HM11
Catalog number
MDWL1_HM11
Device description
HM11 Device
Published
2025-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014100680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014100680008600141006808600141006800860014100680

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
960475866
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015454706RocotoMD62 Tx Device - MDWL2_B1J1TX2026-02-26
00860015454713RocotoMD62 Rx Device - MDWL2_B1J1RX2026-02-26
00860015454720RocotoMD11 Tx device - MDWL1_C1N1TX2026-02-26
00860015454737RocotoMD11 Rx device - MDWL1_B1J1RX2026-02-26
00860015454744RocotoSL11 device - Wireless Camera - MDMP1_SL11_1STE122026-02-26
00860015454751RocotoSL11 device Sterilizable Cover - AMN_ASM_10302026-02-26
00860015454768RocotoMD52 Tx - MDWL2_B1P1TX2026-02-26
00860015454775RocotoMD52 Rx - MDWL2_B3P1RX2026-02-26
00860015454782RocotoHM11 Device - MDWL1_HM112026-02-26
00860014100604AmimonMD62 Tx device - MDWL2_B1J1TXMDWL2_B1J1TX2025-06-24
00860014100611AmimonMD62 Rx device - MDWL2_B1J1RX MDWL2_B1J1RX2025-06-24
00860014100628AmimonMD11 Tx device - MDWL1_C1N1TXMDWL1_C1N1TX2025-06-24
00860014100635AmimonMD11 Rx device - MDWL1_B1N1RXMDWL1_B1N1RX2025-06-24
00860014100642AmimonSL11 device - Wireless Camera - MDMP1_SL11_1STE12MDMP1_SL11_1STE122025-06-24
00860014100659AmimonSL11 Sterilizable Cover - AMN_ASM_1030AMN_ASM_10302025-06-24
00860014100666AmimonMD52 Tx device - MDWL2_B1P1TXMDWL2_B1P1TX2025-06-24
00860014100673AmimonMD52 Rx device - MDWL2_B3P1RXMDWL2_B3P1RX2025-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810186670238Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670245Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670252Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670269Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670276Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670283Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670290Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670306Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670313Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670320Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670337Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670344Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670351Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670368Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670375Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670382Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670399Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670221Enova IlluminationEnova Illumination, Inc.HPP2026-03-31
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00840277411082MedLED SpectraRIVERPOINT MEDICAL, LLCHPP2025-10-28