Data / Medical devices / Netherlands / CooperSurgical Distribution B.V.
CooperSurgical Distribution B.V.: FDA-registered device maker in Herten Limburg, Netherlands, 44 510(k) clearances
CooperSurgical Distribution B.V. is registered with the FDA (registration 3014755376) in Herten Limburg, Netherlands. It lists 9 device types. The FDA files 44 510(k) clearances under its listings, the newest dated June 12, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014755376
- Address
- De Grinderij 1, Herten Limburg, Netherlands, 6049 GH
- Owner or operator
- COOPERSURGICAL, INC. (9002384)
- Roles
- Exporter to the US
- First device listed
- December 5, 2008
- Registered through
- 2027
- Brand names listed
- 10100060A, 10105060A, 10100500A, 10100060D, 10105060D, 10100500D, 10100060F, 10105060F, 10100500F, 10100060M, 10105060M, 10100500M, 10264010A, 10984010A, 10264010D, 10984010D, 10264010F, 10984010F, 10300060, 10301010, 10305060, 10310060, 10311010, 10315060 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Exporter to the US | accessdata.fda.gov |
| Cannula, Intrauterine Insemination | MFD | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Assisted Reproduction | MQF | 2 | Exporter to the US | accessdata.fda.gov |
| Extractor, Vacuum, Fetal | HDB | 2 | Exporter to the US | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Exporter to the US | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 2 | Exporter to the US | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Exporter to the US | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2019 | K191291 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| May 10, 2019 | K182959 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| March 2, 2018 | K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| October 13, 2017 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| July 22, 2016 | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| February 29, 2016 | K152932 | BlastGen | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| February 17, 2015 | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| January 20, 2015 | K143498 | LifeGlobal Global HP | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| June 16, 2014 | K140317 | EMBRYOGEN | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| May 14, 2014 | K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| April 29, 2014 | K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| April 16, 2014 | K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | MQL | Substantially Equivalent | Origio A/S | accessdata.fda.gov |
| May 3, 2012 | K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| January 14, 2011 | K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| June 3, 2010 | K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| April 5, 2010 | K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| September 19, 2008 | K081639 | ICSI CUMULASE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| October 2, 2006 | K061145 | SPERMSLOW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 28, 2006 | K060983 | BIOPSY MEDIUM, MODEL REF 1062 | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| May 19, 2006 | K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| November 22, 2004 | K041284 | MEDICULT IVM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 25, 2004 | K040530 | MEDIA CULTURE SYSTEM | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| December 19, 2003 | K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER | MQF | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| August 20, 2003 | K030490 | ISM1+, IMS2+, AND UTM+ | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| June 27, 2003 | K031486 | BLASTFREEZE AND BLASTTHAW | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 11, 2002 | K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | MQH | Substantially Equivalent | Humagen Fertility Diagnostics, Inc. | accessdata.fda.gov |
| February 11, 2002 | K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE | HHW | Substantially Equivalent | Sims Portex , Ltd. | accessdata.fda.gov |
| August 3, 2001 | K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | MQE | Substantially Equivalent | Sims Portex , Ltd. | accessdata.fda.gov |
| March 22, 2001 | K003404 | SUPRASPERM SYSTEM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 20, 2000 | K991279 | MEDI-CULT UNIVERSAL IVF-MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| May 4, 2000 | K991332 | MEDI-CULT SPERM PREPARATION - MEDIUM; | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| May 4, 2000 | K991327 | MEDI-CULT FLUSHING MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| March 13, 2000 | K000628 | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 | MQE | Substantially Equivalent | Sims Portex , Ltd. | accessdata.fda.gov |
| March 7, 2000 | K991470 | MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 28, 2000 | K991335 | MEDI-CULT FREEZING & THAWING PACKS | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 28, 2000 | K991333 | MEDI-CULT SPERM FREEZE MEDIUM | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 25, 2000 | K991330 | MEDI-CULT LIQUID PARAFFIN | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| February 25, 2000 | K991329 | MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE | MQL | Substantially Equivalent | Medicult A/S | accessdata.fda.gov |
| July 26, 1999 | K990350 | WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 | MQF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 26, 1999 | K990349 | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST | MQF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 26, 1999 | K990348 | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N | MQF | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
| July 19, 1999 | K991173 | <GENX> FERTILIZATION MEDIA-HTF | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| January 16, 1997 | K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | MFD | Substantially Equivalent | Marlow Surgical Technologies, Inc. | accessdata.fda.gov |
| May 4, 1994 | K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | HDB | Substantially Equivalent | Neward Enterprises, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Intrauterine Insemination
- All makers of Accessory, Assisted Reproduction, Exempt
- All makers of Media, Reproductive
- All makers of Pessary, Vaginal
- All makers of Needle, Assisted Reproduction
- All makers of Catheter, Assisted Reproduction
Updated June 12, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.