FDA Registration
Active
🇨🇷 Costa Rica
COOPER MEDICAL, SRL
Reg #: 3014295858
·
FEI: 3014295858
·
Expires 2026
Products
11
Proprietary Names
305
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- COOPER MEDICAL, SRL
- Registration Number
- 3014295858
- FEI Number
- 3014295858
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edificio N B49, 51 Ave 0, Parque Industrial Zona Franca Coyol
- City
- La Garita Alajuela
- Country
- CR
Owner / Operator
- Firm Name
- COOPERSURGICAL, INC.
- Operator Number
- 9002384
- Address
- 95 CORPORATE DRIVE, --
- City
- Trumbull
- State
- CT
- Postal Code
- 06611
- Country
- US
- Correspondent
- Brian Szeremeta
US Agent
- Business Name
- COOPER SURGICAL
- Contact Name
- Brian Szeremeta
- Address
- 95 Corporate Drive, TRUMBULL, CONNECTICUT, 06611, UNITED STATES
- City
- Trumbull
- State
- CT
- ZIP
- 06611
- Country
- US
- [email protected]
- Phone
- 203 6015200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2008-03-26 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2020-01-10 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2008-03-14 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2018-05-01 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2018-06-21 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2023-11-06 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2021-05-19 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2019-09-17 |
| Cannula, Intrauterine Insemination | MFD | Class 2 | Obstetrics/Gynecology | No | 2018-05-01 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2020-01-10 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2016-01-14 |
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
PIPETTES
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
Human Serum Albumin
SAGE Vitrification Warming Kit
SAGE Vitrification Kit
SAGE Vitrification Warming Kit
ViaBL Super-Fast Blastocyst Warming Kit ART-8035
ART-8035, ART-8035A, ART-8035D
ViaBL(TM) SUPER-FAST VITRIFICATION KIT ART-8023/ART-8023D/ART-8023M
QA Medium w/HEPES
QA Fertilization Medium
QA Protein + Blastocyst Medium
QA Protein + Fert. Medium
QA Protein + Cleavage Medium
QA Blastocyst Medium
QA Cleavage Medium
Acidified Medium w/HEPES
SynVitro® Hyadase 15115001
15115001F
15115001D
15115001A
SynVitro® Hyadase 1511
15115001X
Embryo Replacement Catheter (Wallace)
global® Blastocyst Fast Freeze Kit
global® Blastocyst Fast Thawing Kit
SpermSlow
10944000A
SpermSlow 1094
SpermSlow 10944000M
10944000D
SpermSlow 10944000
10944000F
10300060A, 10301010A, 10305060A, 10310060A, 10311010A, 10315060A
Universal IVF Medium
10300060, 10301010, 10305060, 10310060, 10311010, 10315060
10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F
10300060D, 10301010D, 10305060D, 10310060D, 10311010D, 10315060D
10300060M, 10301010M, 10305060M, 10310060M, 10311010M, 10315060M
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
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
PureCeption 24-Determination Bi-Layer Kit
PureCeption, Lower & Upper Phase
PureCeption 100% Isotonic Solution
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
Acidified Tyrodes Solution
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)