FDA.reportPublic FDA data

MIRI Time-Lapse Incubator

Primary DI
04779041940298
Brand
MIRI Time-Lapse Incubator
Company
ESCO MEDICAL TECHNOLOGIES UAB
Model
MIRI TL6
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
2026-01-14
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
MQGAccessory, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151357000MIRI TLAt Medical Uab2016-04-22MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04779041940298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04779041940298047790419402984779041940298

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
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
04779041940243Multiroom IVF incubatorMIRI Humidity2026-01-14
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
05712714676123ES serverVitrolife A/SMQG2026-04-16
05712714676222EmbryoViewerVitrolife A/SMQG2026-04-16
04779041940144Dish for MIRI TLESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940212Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940229Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQG2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQG2025-09-30
05060554120024CODARESEARCH INSTRUMENTS LIMITEDMQG2024-09-20
16975737430110MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430113MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430106MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
26975737430001MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
00370275091011FS DispenserForward Science Technologies LLCMQG2024-02-21
05055270911643RocketROCKET MEDICAL PLCMQG2023-11-03
05055270984524RocketROCKET MEDICAL PLCMQG2023-10-31
05055270909060RocketROCKET MEDICAL PLCMQG2023-10-30
05055270909329RocketROCKET MEDICAL PLCMQG2023-10-30
05055270984463RocketROCKET MEDICAL PLCMQG2023-10-30
05055270911582RocketROCKET MEDICAL PLCMQG2023-10-24
00827002444294COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MQG2023-08-15
03661532000318STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5CRYO BIO SYSTEMMQG2020-11-03
03661532000349STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20CRYO BIO SYSTEMMQG2020-11-03
03661532000356STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000363STERILE CBS 0.5 ML STRAW FOR SPERM WITH GREEN COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000370STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000479STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000486STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000493STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND YELLOW FLEXIBLE ROD / BLISTER 5X1CRYO BIO SYSTEMMQG2020-11-03
03661532000509STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000516STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03