Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014755376

FEI Number

3014755376

Entity Name

CooperSurgical Distribution B.V.

City/State/Country

Herten Limburg, NL

Establishment Address

De Grinderij 1, Herten Limburg 6049 GH, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

COOPERSURGICAL, INC. (Owner Number: 9002384)

Owner / Operator Contact Address

95 CORPORATE DRIVE, --, Trumbull, CT 06611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053552

PMA Number

N/A

All Registered Proprietary Names

BlastGen 12050003 12050003D 12050003A 12050003M 12050003F 1205 MediCult IVM System 82214010 82214010A 82214010D 82214010M 10620010D Biopsy Medium 10620010A 10620010F 10620010 10620010M MityVac w/Universal Vacuum Release [UVR] Wallace Dual Lumen 16G global® DMSO Blastocyst Vitrification Kit global DMSO Blastocyst Vitrification Warming Kit Sequential Cleav 83030010, 83030060, 83040010, 83040060 83030010M, 83030060M, 83040010M, 83040060M ORIGIO Sequential Cleav ORIGIO Sequential Fert Sequential Cleav w/o phenol red 8303 Sequential Cleav w/o phenol red 83030060 Sequential Cleav w/o phenol red 83030010 Sequential Cleav with phenol red 83040010 83010010F, 83010060F, 83020010F, 83020060F 83030010A, 83030060A, 83040010A, 83040060A Sequential Fert with phenol red 8302 Sequential Fert 83010010, 83010060, 83020010, 83020060 83030010D, 83030060D, 83040010D, 83040060D Sequential Fert with phenol red 83020060 Sequential Cleav with phenol red 83040060 83010010M, 83010060M, 83020010M, 83020060M 83010010D, 83010060D, 83020010D, 83020060D 83030010F, 83030060F, 83040010F, 83040060F Sequential Fert with phenol red 83020010 83010010A, 83010060A, 83020010A, 83020060A Sequential Fert w/o phenol red 83010060 Sequential Fert w/o phenol red 83010010 Sequential Cleav with phenol red 8304 Sequential Fert w/o phenol red 8301 LGFR-100M, LGFR-500M Global w/HEPES LGGH-050, LGGH-050, LGGH-250, LGGH-500 Washing mHTF w/HEPES & Phenol Red Media Culture System global Collect Global w/Hepes PGD Media HTF w/Hepes Global w/HEPES LGGH-050M, LGGH-050M, LGGH-250M, LGGH-500M LGFR-100, LGFR-500 Global Collect GCOL-100, GCOL-500 Global Collect GCOL-100M, GCOL-500M Wallace Oocyte Needles Trial Transfer Catheter (Wallace) 16125000M ICSI Cumulase ICSI Cumulase 16125000 16125000A 16125000F 16125000D ICSI Cumulase 1612 ORIGIO Sequential Blast 83050010, 83050060, 83060010, 83060060 83050010A, 83050060A, 83060010A, 83060060A 83050010D, 83050060D, 83060010D, 83060060D 83050010M, 83050060M, 83060010M, 83060060M 83050010F, 83050060F, 83060010F, 83060060F 10520010, 11520010 10520010F, 11520010F 10520010A, 11520010A UTM Transfer Medium 10520010M, 11520010M 10520010D, 11520010D Protein Supplement LGPS-020M, LGPS-050M, LGPS-605M LGPS-020, LGPS-050, LGPS-100, LGPS-125, LGPS-250, LGPS-605 SpermSlow 10944000A SpermSlow 1094 SpermSlow 10944000M 10944000D SpermSlow 10944000 10944000F 10670010D Sperm Freezing Medium Sperm Freezing Medium 1067 10670010M 10670010F Sperm Freezing Medium 10670010 10670010A Embryo Thawing Pack 10984010 10264010F, 10984010F Embryo Freezing pack 10264010 10264010A, 10984010A 10264010D, 10984010D Embryo Freezing pack 10264010M Embryo Thawing Pack 10984010M 17G Wallace Dual Lumen SupraSperm 90 SupraSperm 100 LifeGlobal Global HP Wallace Oocyte Retrieval Needles Artifical Insemination Catheter (Wallace) 77020003D 77010003M, 77020003M 77010003A SAGE 1-Step GM-CSF 77010003 77020003A 77020003F 77010003F 77020003 77010003D INSORB Subcuticular Stapler- REF 2030 Wallace Pessaries EmbryoGen 12040003 EmbryoGen/BlastGen 12062003 12040003M, 12062003M 12040003A, 12062003A 12040003D, 12062003D ORIGIO Sperm Wash 84051010 ORIGIO Gradient 100 84000060 ORIGIO Sperm Wash 84050060 84000060F, 84002060F, 84004125F, 84010060F, 84021210F, 84022010F, 84022060F, 84050060F, 84051010F, 84055060F 84000060A, 84002060A, 84004125A, 84010060A, 84021210A, 84022010A, 84022060A, 84050060A, 84051010A, 84055060A CCB Density Gradient ORIGIO® Gradient 90 w/o Gentamicin 84905060 (8490) ORIGIO Gradient 100 ORIGIO Gradient 90 ORIGIO Gradient 40/80 Sperm Wash ORIGIO Gradient 40 ORIGIO Gradient 80 ORIGIO Gradient 100 84004125 ORIGIO Sperm Wash 8405 ORIGIO Gradient 40/80 84021210 ORIGIO Gradient 40/80 84022060 ORIGIO Gradient 100 84002060 84000060D, 84002060D, 84004125D, 84010060D, 84021210D, 84022010D, 84022060D, 84050060D, 84051010D, 84055060D ORIGIO Sperm Wash 84055060 84000060M, 84002060M, 84004125M, 84010060M, 84021210M, 84022010M, 84022060M, 84050060M, 84051010M, 84055060M ORIGIO Gradient 40/80 84022010 ORIGIO® Gradient 90 w/o Gentamicin 84905060D (8490) ORIGIO Gradient 90 84010060 Acidified Tyrodes Solution LifeGlobal® Global® Total® LP for Fertilization LifeGlobal® Global® Total® w/HSA LifeGlobal® Global® Total® for Fertilization w/HSA LifeGlobal® Global® Total® LP LifeGlobal® Global® Total® LP w/Hepes LifeGlobal® Global® Total® w/HEPES w/HSA HTF Media FERTILIZATION MEDIA 67020010D, 67020060D SAGE 1-Step 67010010, 67010060 67010010D, 67010060D 67020010F, 67020060F 67010010M, 67010060M 67010010A, 67010060A 67010010F, 67010060F 67020010A, 67020060A 67020010M, 67020060M 67020010, 67020060 83100060M, 83100125M, 83110060M, 83110125M ORIGIO Handling Medium ORIGIO Handling Medium 83110125D ORIGIO Handling Medium 8310 83100060F, 83100125F, 83110060F, 83110125F ORIGIO Handling Medium 83110060D 83100060A, 83100125A, 83110060A, 83110125A ORIGIO Handling Medium 83100060D 83100060, 83100125, 83110060, 83110125 ORIGIO Handling Medium 83100125D ORIGIO Handling Medium 8311 Liquid Paraffin Liquid Paraffin 1010 Liquid Paraffin 10105060 10100060A, 10105060A, 10100500A Liquid Paraffin 10100060 10100060M, 10105060M, 10100500M Liquid Paraffin 10100500 10100060D, 10105060D, 10100500D 10100060F, 10105060F, 10100500F 10840125M, 10845060M Flushing Medium w/o Heparin Flushing medium 10840125, 10845060 10840125F, 10845060F 10840125D, 10845060D 10840125A, 10845060A Global Total for Fertilization LGTF-020, LGTF-050, LGTF-100 Global Total LGGT-030M, LGGT-060M, LGGT-100M Life Global Total for Fertilization LifeGlobal Total w/HEPES LifeGlobal Total Global Total LGGT-030, LGGT-060, LGGT-100 Global Total for Fertilization LGTF-020M, LGTF-050M, LGTF-100M Global Total w/HEPES LGTH-050M, LGTH-100M, LGTH-250M Global Total w/HEPES LGTH-050, LGTH-100, LGTH-250 Stylet for Embryo Replacement Catheter 10890001A, 10905000A PVP Clinical Grade PVP Medium PVP Clinical Grade 10905000 10890001D, 10905000D PVP Medium 1089 10890001M, 10905000M PVP Medium 10890001 PVP Clinical Grade 1090 10890001F, 10905000F Sperm Preparation Medium 10690060A, 10691010A, 10695060A, 10700060A, 10701010A, 10702010A, 10705060A 10690060D, 10691010D, 10695060D, 10700060D, 10701010D, 10702010D, 10705060D 10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F 10690060M, 10691010M, 10695060M, 10700060M, 10701010M, 10702010M, 10705060M Embryo Replacement Catheter (Wallace) BlastThaw BlastFreeze 10542010 10542010M 10542010F 10532010F 10542010D 10542010A Global Fertilization GLOBAL Embryo Culture and Transfer LGGG-020, LGGG-050, LGGG-100, LGGF-020, LGGF-050, LGGF-100 LGGG-020M, LGGG-050M, LGGG-100M, LGGF-020M, LGGF-050M, LGGF-100M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2008-12-05
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2019-06-13
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2018-06-21
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-05-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-05-17
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2019-05-22
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2018-05-07
MFD	Cannula, Intrauterine Insemination	Obstetrics/Gynecology	Class 2	884.5250	2018-05-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2023-11-06
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2018-05-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-04-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-05-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-05-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-03-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-13

Official Correspondent

Brian Szeremeta

US Agent Details

Brian Szeremeta Business: COOPER SURGICAL Email: FURLS-Codes@coopersurgical.com Phone: (203) 6015200

Related Public Records

Same Entity

COOPERSURGICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611604	LEISEGANG FEINMECHANIK-OPTIK GMBH	BERLIN, DE
1627186	Lone Star Medical Products	Stafford, TX, US
8010251	HBH MEDIZINTECHNIK GMBH	TUTTLINGEN Baden-Wurttemberg, DE
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K963031	Genx Intl., Inc.	GENXCATHETER	1996-10-21
K933654	Johnson & Johnson Medical, Inc.	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	1995-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-05	CooperSurgical, Inc.	2	Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014755376. Last updated year: 2026. Please use registration number 3014755376 when referencing this establishment in official correspondence.