FDA.report

HARIOMED

Primary DI
06975183900086
Brand
HARIOMED
Company
Hua Yue Medical Technology Co., Ltd.
Model
Harioculture HI-2
Published
2025-03-14
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

Related Records

Product Codes

CodeName
PUBAccessory, Assisted Reproduction, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUBAccessory, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975183900086PrimaryGS10

GMDN Terms

TermDefinition
Assisted reproduction heater/incubatorAn electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.

Sterilization Methods

Method

Regulatory Flags

DUNS number
625413598
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
06975183900123HARIOMEDIW-A1800M2025-03-17
06975183900147HARIOMEDIW-A9502025-03-17
06975183900154HARIOMEDIW-A1350A2025-03-17
06975183900161HARIOMEDIW-A1350C2025-03-17
06975183900178HARIOMEDIW-A1350S2025-03-17
06975183900024HARIOMEDIMS-320D2025-03-14
06975183900031HARIOMEDIMS-320U2025-03-14
06975183900048HARIOMEDIMS-320D-S2025-03-14
06975183900055HARIOMEDIMS-320U-S2025-03-14
06975183900062HARIOMEDIBI-D1012025-03-14
06975183900079HARIOMEDHarioculture DI-42025-03-14
06975183900093HARIOMEDHarioculture HI-42025-03-14
06975183900109HARIOMEDIW-A18002025-03-14
06975183900116HARIOMEDIW-A1800S2025-03-14
06975183900130HARIOMEDIW-A1800D2025-03-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04779041940168Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940199Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940267Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940311MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940809Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940816Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940243Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940465Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940472Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940496Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940502Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940519Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940526Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940533Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940540Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940557Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940564Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940700Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940441Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-07
06975183900062HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900079HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900093HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
05060554120956K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
05060554120963K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
00888937014488TITANRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014587MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014600MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014648MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014655TITANRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014662TITANRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20