Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instruments
Gynaecology and fertility treatment instruments
EMDN code Z120802
Manufacturers registered in Europe (EUDAMED) 23
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 81
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Wallace | registered |
| ORIGIO INC. | United States | STRIPPER | registered |
| RESEARCH INSTRUMENTS LIMITED | United Kingdom | RI Pipettes EZ-Tip EZ-Strip EZ-Squeeze EZ-Grip | K161275 (2017) |
| Aesculap, Inc. Present in Europe in other categories | United States | AESCULAP ADTEC MONOPOLAR | K010752 (2001) |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Jarit® | registered |
| Coopersurgical, Inc. Present in Europe in other categories | United States | 16G Wallace Dual Lumen Oocyte Recovery Set 17G Wallace Dual Lumen Oocyte Recovery Set 16G Wallace Single Lumen Oocyte Recovery Set 17G Wallace Single Lumen Oocyte Recovery Set 17G Wallace Single Lumen Oocyte Needle 18G Wallace Single Lumen Oocyte Recovery Set | K191291 (2019) |
| KITAZATO CORPORATION | Japan | Kitazato OPU Needle OPU Needle Kitazato OPU Needle with Connection Tube, Type2-v12 Kitazato OPU Needle with Connection Tube, Type2-v11 Kitazato OPU Needle with Connection Tube, Type2-v13 Kitazato OPU Needle with Connection Tube, Type2-v15 | K162881 (2017) |
| Arsci Inc. | Canada | MICROTOOLS (Denuding Pipette) MICROTOOLS (Biopsy Pipette) MICROTOOLS (Injection Pipiette) MICROTOOLS (Holding Pipette) MICROTOOLS (Polar Body Biopsy Pipette) MICROTOOLS (Assisted Hatching Pipette) | registered |
| W.O.M. World of Medicine GmbH | United States | Tube set for irrigation, single-use Tube set for suction, single-use Aquilex® Fluid Control System Tube set for vacuum incl. filter, 30-day use Tube set for irrigation, single use GYN-Pump | K173489 (2018) |
| WOMANCARE GLOBAL TRADING, INC. | – | WomanCare Global Ipas EasyGrip® Cannula, 10mm WomanCare Global Ipas EasyGrip® Cannula, 6mm WomanCare Global Ipas EasyGrip® Cannula, 5mm WomanCare Global Ipas EasyGrip® Cannula, 4mm WomanCare Global Ipas EasyGrip® Cannula, 12mm WomanCare Global Ipas EasyGrip® Cannula, 7mm | registered |
| Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | – | Labotect | registered |
| East Coast Surgical Inc. | – | East Coast Surgical Instruments | registered |
| LABORATOIRE CCD | France | RIGISTER CUPULE 35 mm SLIDING RIGISTER CUPULE 30 mm RIGISTER CUPULE 30 mm SLIDING RIGISTER CUPULE 25 mm RIGISTER CUPULE 25 mm SLIDING RIGISTER CUPULE 35 mm | registered |
| Panpac Medical Corporation | Taiwan | – | K161106 (2017) |
| CIVCO Medical Instruments Co., Inc. | United States | Needle Guide | registered |
| VITROMED GmbH Present in Europe in other categories | Germany | V-DENUPET | K192146 (2020) |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | Hysteroscopic Fluid Management Hysteroscopic Roller Base Hysteroscopic Fluid Management System Stand Hysteroscopic Outflow Tube Set TRUCLEARTM Hysteroscopic Inflow Tube Set | registered |
| Guangzhou PINZHI Medical Device Co., Ltd. | China | Denudation Pipettes | K250838 (2025) |
| STRYKER CORPORATION Present in Europe in other categories | United States | Fluid Safe ThermaClear | registered |
| Cook, Inc. | United States | Cook | K151018 (2016) |
| Dornier Medtech America, Inc. Present in Europe in other categories | United States | Dornier MedTech | registered |
| MedGyn Products, Inc. | United States | MedGyn collection set MedGyn Pipette II MedGyn Pipette MedGyn Pipette IV | registered |
| Minerva Surgical, Inc. | United States | Symphion Operative Hysteroscopy System Prime Controller Symphion Controller - Refurbished Symphion Fluid Deficit Readout Symphion Operative Hysteroscopy System Prime Controller- Refurbished Symphion Controller | registered |
| Thermedx, LLC | United States | Fluid Management System Urology Set Tubing Set - Single Lumen, Inflow with Dual Outflow Luer Lock Set, Single Lumen | K210628 (2021) |
| Chongqing Jinshan Science & Technology (Group) Co., Ltd | China | GynoVision | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| Gynetics Medical Products NV | United States | Follicle Aspiration needle - single lumen flush Follicle Aspiration needle - single lumen Follicle Aspiration needle - double lumen flush | K013497 (2001) |
| Richard Wolf GmbH Present in Europe in other categories | Germany | – | registered |
| SHENZHEN VITAVITRO BIOTECH CO.,LTD. | China | VitaVitro | K240523 (2024) |
| Boston Scientific Corp Present in Europe in other categories | United States | Asurys™ | K251273 (2026) |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| GYNEX CORPORATION | United States | Gynex | registered |
| Olympus Winter & Ibe GmbH Present in Europe in other categories | Germany | Olympus | registered |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Premier | registered |
| Atc Technologies, Inc. | United States | Modulap | K121343 (2013) |
| FUJIFILM IRVINE SCIENTIFIC, INC. | – | CryoTip® | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI | K171440 (2017) |
| APICAL INSTRUMENTS | United States | – | registered |
| ATC Technologiess Inc. | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Axora Medical, Inc. | United States | – | registered |
| BURAK GLOBAL IC VE DIS TIC LTD STI | Türkiye | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Centerpiece Holdings LLC | United States | – | registered |
| Chongquin Jinshan Science & Technology (Group) Co., Ltd. | China | – | K172151 (2018) |
| Fresenius Kabi AG Present in Europe in other categories | Germany | – | registered |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Gebruder Renggli AG | Switzerland | – | registered |
| Gimbo Medical Technology Shenzhen Co., Ltd. | China | – | K253121 (2026) |
| Guenter Bissinger Medizintechnik GmbH | Germany | – | registered |
| Infus Medical (Thailand) Co., Ltd. | Thailand | – | registered |
| Infus Medical Co., Ltd. | Thailand | – | registered |
| Integra LifeSciences Corporation Present in Europe in other categories | United States | – | K103726 (2012) |
| JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. | China | – | registered |
| Jabil Inc. | United States | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K000806 (2000) |
| KOSCHER & WUERTZ GMBH | Germany | – | registered |
| Katecho, Inc. | United States | – | registered |
| LIFEGLOBAL GROUP, LLC Present in Europe in other categories | United States | – | K152581 (2016) |
| Life Science Outsourcing, Inc. | United States | – | registered |
| MEDRES Medical Engineering Ltd. | Hungary | – | registered |
| MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI | Türkiye | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Modo Inc | United States | – | registered |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Novanta Medical GmbH Present in Europe in other categories | Germany | – | registered |
| Olympus America, Inc. Present in Europe in other categories | United States | – | registered |
| Pacific Hospital Supply Company Limited Present in Europe in other categories | Taiwan | – | registered |
| Peter's Technology (Suzhou) Co., Ltd. | China | – | registered |
| Primo Medical Group, Inc | United States | – | registered |
| Rocket Medical Plc Present in Europe in other categories | United Kingdom | – | K032015 (2003) |
| SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare | United States | – | registered |
| STERIPAC GMBH | Germany | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Sunlight Medical, Inc. | United States | – | K092554 (2010) |
| TONTARRA MEDIZINTECHNIK GMBH Present in Europe in other categories | Germany | – | registered |
| Willian A. Cook Australia Pty, Ltd. | Australia | – | K171625 (2018) |
| Zhejiang Horizon Medical Technology Co., Ltd. | China | – | K232163 (2024) |
| Zinnanti Surgical Design Group Inc | United States | – | registered |
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