FDA.reportPublic FDA data

ECLIPSE Ti2-U IVF US

Primary DI
04549921600020
Brand
ECLIPSE Ti2-U IVF US
Company
NIKON CORPORATION
Model
MEA54500
Published
2021-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MTXMicroscope And Microscope Accessories, Reproduction, Assisted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTXMicroscope And Microscope Accessories, Reproduction, AssistedObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04549921600020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04549921600020045499216000204549921600020

GMDN Terms#

Term, Definition table
TermDefinition
Inverted-stage light microscopeA magnification instrument designed with illumination placed at the top with the stage (the specimen platform) below, and the optics on the bottom for microscopic study of large specimens by transmitted light. It is typically used in the laboratory for investigation and research. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a specimen stage, a condenser to focus the light on the specimen, and a source of light. It is typically used for the examination of tissue cultures in all types of culture vessels (e.g., Petri dishes, culture bottles) and also in microtest and microtitre plates.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690550868
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
04549921600341ECLIPSE Ti2-I USMEA543152025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909262200088Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200132Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200187ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200194ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200200ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200217ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200224ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200255ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200262ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200279ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200309ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200347ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200354ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200385ZEISS AxiolabCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200613Zeiss Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200620ZEISS Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200156Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-05-19
00664816005316LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
00664816005323LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
04582754071520IX73 2PORT FRAMEEVIDENT CORPORATIONMTX2025-10-31
04582754071674TRANSMITTED ILLUMINATOREVIDENT CORPORATIONMTX2025-10-31
04582754073340CONTROL BOX MEVIDENT CORPORATIONMTX2025-10-31
04582754073357HAND SWITCHEVIDENT CORPORATIONMTX2025-10-31
04582754073364LED POWER SUPPLYEVIDENT CORPORATIONMTX2025-10-31
04582754073371EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073388EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073609UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754073838UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754074095UIS2 OBJECTIVE LENS FOR BIOLOGYEVIDENT CORPORATIONMTX2025-10-31
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MTX2025-09-30