FDA.reportPublic FDA data

Multiroom IVF incubator

Primary DI
04779041940243
Brand
Multiroom IVF incubator
Company
ESCO MEDICAL TECHNOLOGIES UAB
Model
MIRI Humidity
Device description
The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a stable culture environment at or near body temperature and CO2/N2 orpremixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments.
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PUBAccessory, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUBAccessory, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04779041940243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04779041940243047790419402434779041940243

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
365831125
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
04779041940144Dish for MIRI TLCultureCoin2026-01-15
04779041940168Multiroom IVF incubatorMini MIRI Dry2026-01-15
04779041940199Multiroom IVF incubatorMini MIRI Humidity2026-01-15
04779041940212Multiroom IVF incubatorMIRI2026-01-15
04779041940229Multiroom IVF incubatorMIRI2026-01-15
04779041940267Multiroom IVF incubatorMIRI II-122026-01-15
04779041940311MIRI Time-Lapse IncubatorMIRI TL122026-01-15
04779041940809Multiroom IVF incubatorMIRI M Chamber2026-01-15
04779041940816Multiroom IVF incubatorMIRI M Docking Station2026-01-15
04779041940106MIRIMIRI2016-10-13
04779041940113MIRI TLMIRI TL2016-10-13
04779041940298MIRI Time-Lapse IncubatorMIRI TL62026-01-14
04779041940465Multi-zone ART WorkstationMAW-4D2026-01-14
04779041940472Multi-zone ART WorkstationMAW-3D2026-01-14
04779041940496Multi-zone ART WorkstationMAW-6D2026-01-14
04779041940502Multi-zone ART WorkstationMAW-6D2026-01-14
04779041940519Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940526Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940533Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940540Multi-zone ART WorkstationMAW-6D-MP2026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
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
04580647510125EC10-120MDASTEC CO.,LTD.PUB2026-01-12
04779041940458Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-12
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
06975183900086HARIOMEDHua 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