COOPER MEDICAL, SRL

FDA Device Registration & Listing · La Garita Alajuela, CR · Registration 3014295858

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014295858
FEI Number
3014295858
Entity Name
COOPER MEDICAL, SRL
City/State/Country
La Garita Alajuela, CR
Establishment Address
Edificio N B49, 51 Ave 0, Parque Industrial Zona Franca Coyol, La Garita Alajuela 20113, CR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
COOPERSURGICAL, INC. (Owner Number: 9002384)
Owner / Operator Contact Address
95 CORPORATE DRIVE, --, Trumbull, CT 06611, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

QA Blastocyst Freeze Kit QA Embryo Freeze Kit QA Sperm Freeze Kit QA Thaw Kit HBA Milex Silicone Pessaries global® DMSO Blastocyst Vitrification Kit global DMSO Blastocyst Vitrification Warming Kit 67020010D, 67020060D SAGE 1-Step 67010010, 67010060 67010010D, 67010060D 67020010F, 67020060F 67010010M, 67010060M 67010010A, 67010060A 67010010F, 67010060F 67020010A, 67020060A 67020010M, 67020060M 67020010, 67020060 SupraSperm 90 SupraSperm 100 Oil for Tissue Culture Trial Transfer Catheter (Wallace) ORIGIO Sequential Blast 83050010, 83050060, 83060010, 83060060 83050010A, 83050060A, 83060010A, 83060060A 83050010D, 83050060D, 83060010D, 83060060D 83050010M, 83050060M, 83060010M, 83060060M 83050010F, 83050060F, 83060010F, 83060060F SynVitro® Flush 15840125 15840125A SynVitro® Flush w/o Heparin 15840125 15840125F SynVitro® Flush without Heparin 15840125 15840125D Wallace Oocyte Needles Wallace Oocyte Retrieval Needles 10620010D Biopsy Medium 10620010A 10620010F 10620010 10620010M MediCult IVM System 82214010 82214010A 82214010D 82214010M Stylet for Embryo Replacement Catheter HTF Media FERTILIZATION MEDIA 10840125M, 10845060M Flushing Medium w/o Heparin Flushing medium 10840125, 10845060 10840125F, 10845060F 10840125D, 10845060D 10840125A, 10845060A Wallace Embryo Transfer Catheter INSORB Subcuticular Stapler- REF 2030 BlastThaw BlastFreeze 10542010 10542010M 10542010F 10532010F 10542010D 10542010A 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 15135001D 15135001M SynVitro® Hyadase 1513 15135001A 77020003D 77010003M, 77020003M 77010003A SAGE 1-Step GM-CSF 77010003 77020003A 77020003F 77010003F 77020003 77010003D PVP 10% Polyvinylpyrrolidon (PVP) 10% PVP 7% INSORB Subcuticular Skin Stapler Quinn's Sperm Washing Medium Invitro Maturation Media [IVM] QA Serum Protein Substitute Vitrification Warming Kit Vitrification Kit & EmbryoGen 12040003 EmbryoGen/BlastGen 12062003 12040003M, 12062003M 12040003A, 12062003A 12040003D, 12062003D TPC Pipettes 10520010, 11520010 10520010F, 11520010F 10520010A, 11520010A UTM Transfer Medium 10520010M, 11520010M 10520010D, 11520010D 17G Wallace Dual Lumen 10670010D Sperm Freezing Medium Sperm Freezing Medium 1067 10670010M 10670010F Sperm Freezing Medium 10670010 10670010A Wallace Dual Lumen 16G Artifical Insemination Catheter (Wallace) 12284001D, 12295002D Medicult Vitrification Cooling and Warming 12284001M, 12295002M 12284001 and 12295002 Medicult Vitrification Cooling and Warming 12284001F, 12295002F 12284001A, 12295002A PICSI Dish Protein Supplement LGPS-020M, LGPS-050M, LGPS-605M LGPS-020, LGPS-050, LGPS-100, LGPS-125, LGPS-250, LGPS-605 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 16125000M ICSI Cumulase ICSI Cumulase 16125000 16125000A 16125000F 16125000D ICSI Cumulase 1612 Embryo Thawing Pack 10984010 10264010F, 10984010F Embryo Freezing pack 10264010 10264010A, 10984010A 10264010D, 10984010D Embryo Freezing pack 10264010M Embryo Thawing Pack 10984010M 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 Phosphate Buffered Saline (PBS) 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 BlastGen 12050003 12050003D 12050003A 12050003M 12050003F 1205 Hyaluronidase 80 U/ml ORIGIO LifeGlobal Global HP 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
POV Semen Analysis Device Hematology Class 2 864.5220 2020-01-10
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2008-03-14
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 2008-03-26
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
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2018-06-21
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2018-05-07
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2018-05-01
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2018-05-07
QQS Stapler, Skin General Hospital Class 1 878.4740 2023-11-06
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 2021-03-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-05-19
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-12-06
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2009-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-12-05
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-04-16
PUC Microtools, Assisted Reproduction (Pipettes), Exempt Obstetrics/Gynecology Class 2 884.6130 2019-09-17
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
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-06-13
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
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2020-01-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-01-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12
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 2020-10-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-03-26
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 2008-03-26
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2016-01-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2020-10-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-03-12

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
3014755376 CooperSurgical Distribution B.V. Herten Limburg, NL
1216677 COOPERSURGICAL, INC. Trumbull, CT, US

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
K933654 Johnson & Johnson Medical, Inc. BLADDER NECK SUPPORT PROTHESIS FITTING KIT 1995-05-04
K112396 Kitazato Medical Co., Ltd. IUI CATHETERS 2012-11-02
K082727 Vitrolife Sweden AB FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN 2009-02-06
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Similar Registrations

Registration Number Establishment Name Location
2031824 Vitrolife Inc. San Diego, CA, US
3014755376 CooperSurgical Distribution B.V. Herten Limburg, NL
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 3014295858. Last updated year: 2026. Please use registration number 3014295858 when referencing this establishment in official correspondence.
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