FDA.reportPublic FDA data

Harioculture TL-16 Time-lapse Incubator

Primary DI
06975183900185
Brand
Harioculture TL-16 Time-lapse Incubator
Company
Hua Yue Medical Technology Co., Ltd.
Model
Harioculture TL-16
Device description
Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.
Published
2025-09-30
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
MQKLabware, Assisted Reproduction
MTXMicroscope And Microscope Accessories, Reproduction, Assisted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2
MQKLabware, Assisted ReproductionObstetrics/Gynecology2
MTXMicroscope And Microscope Accessories, Reproduction, AssistedObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242684000Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.2025-05-22MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975183900185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975183900185069751839001856975183900185

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction incubator/microscope camera systemAn assembly of mains electricity (AC-powered) devices intended to be used during assisted reproduction/in vitro fertilization (IVF) to incubate reproductive biological materials (e.g., gametes and embryos) at closely regulated and monitored temperatures, whilst acquiring, processing, and storing images of the embryo cultures, over the course of development, to assist embryo selection. It consists of an incubator with a built-in digital microscope still camera, monitor, and software; it may include additional supportive devices (e.g., printer). The system may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentrations].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight65Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
625413598
Device count
1
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
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
06975183900048HARIOMEDIMS-320D-S2025-03-14
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

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