TPLC - Total Product Life Cycle

• Device: media, reproductive
• Product Code: MQL
• Regulation Number: 884.6180
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARTSMEDIA DENMARK APS
	SUBSTANTIALLY EQUIVALENT	1
DONNEVIE MEDICAL TECHNOLOGY (SHANGHAI) CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM IRVINE SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM IRVINE SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HAMILTON THORNE INC.
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON THORNE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
HAMILTON THORNE, INC.
	SUBSTANTIALLY EQUIVALENT	1
KITAZATO CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
ORIGIO A/S, A COOPERSURGICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
VITROLIFE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	2
VITROMED GMBH
	SUBSTANTIALLY EQUIVALENT	4
VITROMED LANGENFELD
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2023	1	1
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Chemical Problem	2	2
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Feb-14-2024
2	CooperSurgical, Inc.	II	Apr-06-2023
3	CooperSurgical, Inc.	II	Jan-31-2023
4	CooperSurgical, Inc.	II	Jul-20-2022
5	CooperSurgical, Inc.	II	Oct-13-2020
6	Fujifilm Irvine Scientific, Inc.	II	Feb-06-2024
7	Fujifilm Irvine Scientific, Inc.	II	Apr-01-2023
8	Fujifilm Irvine Scientific, Inc.	II	Nov-17-2021