FDA.reportPublic FDA data

HARIOMED

Primary DI
06975183900048
Brand
HARIOMED
Company
Hua Yue Medical Technology Co., Ltd.
Model
IMS-320D-S
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQJMicromanipulators And Microinjectors, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQJMicromanipulators And Microinjectors, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975183900048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975183900048069751839000486975183900048

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction electromechanical micromanipulatorAn electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [e.g., intracytoplasmic sperm injection] usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625413598
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975183900017Hariomed culture dishTLdish-2*82025-09-30
06975183900185Harioculture TL-16 Time-lapse IncubatorHarioculture TL-162025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleTL-16EX2025-09-30
06975183900208Hariomed humidification boxTL humidification1602025-09-30
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
06975183900055HARIOMEDIMS-320U-S2025-03-14
06975183900062HARIOMEDIBI-D1012025-03-14
06975183900079HARIOMEDHarioculture DI-42025-03-14
06975183900086HARIOMEDHarioculture HI-22025-03-14
06975183900093HARIOMEDHarioculture HI-42025-03-14
06975183900109HARIOMEDIW-A18002025-03-14
06975183900116HARIOMEDIW-A1800S2025-03-14
06975183900130HARIOMEDIW-A1800D2025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975183900024HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
06975183900031HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
06975183900055HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
10850068289544SFG MicropipettorSPECTRUM FERTILITY GROUP INC.MQJ2024-11-12
04589818020562MTK-1VM-Z3NARISHIGE LIFEMED CO., LTD.MQJ2024-11-08
G4252005200My MedicalMy Medical Store LLCMQJ2023-08-27
04260531792584V-DENUPET HANDLEVITROMED GmbHMQJ2022-12-16
04589818020302IM-21VMNARISHIGE LIFEMED CO., LTD.MQJ2020-04-20
04589818020296NTXVM-N3NARISHIGE LIFEMED CO., LTD.MQJ2018-08-30
04589818020272ON4VMNARISHIGE LIFEMED CO., LTD.MQJ2018-06-01
04589818020289NTXVM-N4NARISHIGE LIFEMED CO., LTD.MQJ2018-06-01
05060488042416INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042423INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042430INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042447INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042782INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488043451INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488043611INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044755INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044762INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044779INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044786INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044984INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488041754INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041761INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041778INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041785INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041792INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041808INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041815INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22