FDA.reportPublic FDA data

MIRI Time-Lapse Incubator

Primary DI
04779041940311
Brand
MIRI Time-Lapse Incubator
Company
ESCO MEDICAL TECHNOLOGIES UAB
Model
MIRI TL12
Device description
Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide an environment with controlled temperature, CO2 and other gases for the development ofembryos. This model has an integrated inverted microscope and imaging system for embryo viewing. The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development.
Published
2026-01-15
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
04779041940311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04779041940311047790419403114779041940311

GMDN Terms#

Term, Definition table
TermDefinition
Aerobic laboratory incubatorA mains electricity (AC-powered) device heated by electrical currents passing through a heating block containing simple resistors (usually coils of nickel-chromium wire) for the purpose of growing microorganisms and cells that require oxygen (O2) for growth. Aerobic incubators are typically used for serology and crystallization studies, tissue culture work, paraffin wax embedding and in vitro fertilization (IVF).

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
04779041940809Multiroom IVF incubatorMIRI M Chamber2026-01-15
04779041940816Multiroom IVF incubatorMIRI M Docking Station2026-01-15
04779041940106MIRIMIRI2016-10-13
04779041940113MIRI TLMIRI TL2016-10-13
04779041940243Multiroom IVF incubatorMIRI Humidity2026-01-14
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
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
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