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Emdyca

Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instrumentsGynaecology and fertility treatment instruments

Oocyte aspiration equipment

EMDN code Z12080202

3 manufacturers, 3 models including 3 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 3
  • 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.
ManufacturerCountryRegistered modelsClassContact
Allwinmedical FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States IIa MDR Website info@allwinmedical.com EUDAMED record Report an error
Inti Taiwan EU representative : Luana Med. B.V. (Netherlands) Taiwan I MDR Website EUDAMED record Report an error
William A Cook Australia Pty FDA EU representative : COOK MEDICAL EUROPE LIMITED (Ireland) Australia IIa 93/42 Website EUDAMED record Report an error

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) 17

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.

ManufacturerCountryBrandsFDA clearance
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)
Vitrolife Sweden AB Present in Europe in other categories Sweden Follicle Aspiration Set Single Lumen Follicle Aspiration Set Double Lumen Follicle Aspiration Set Reduced Single Lumen Follicle Aspiration Set Single Lumen, Luer Follicle Aspiration Set Reduced Single Lumen, Luer Follicle Aspiration Set Single Lumen, Luer with Tubing K172050 (2017)
Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung – Labotect 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)
CIVCO Medical Instruments Co., Inc. United States Needle Guide registered
LABORATOIRE CCD France OOCYTE RETRIEVAL NEEDLE30CM G17 OPS CLASSIC WITHOUT VALVE OPS A.R.T. OF C.C.D. ®WITH VALVE OVO A.R.T. OF C.C.D.® NEEDLE 30CM G17 OOCYTE RETRIEVAL NEEDLE 25CM G17 OPS A.R.T. OF C.C.D. ® WITHOUT VALVE 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)
SHENZHEN VITAVITRO BIOTECH CO.,LTD. China VitaVitro K240523 (2024)
ICU MEDICAL, INC. Present in Europe in other categories United States Wallace registered
Cook, Inc. United States – registered
Gimbo Medical Technology Shenzhen Co., Ltd. China – K253121 (2026)
MedGyn Products, Inc. United States – registered
Rocket Medical Plc Present in Europe in other categories United Kingdom – K032015 (2003)
STERIPAC GMBH Germany – registered
Vitrolife A/S Present in Europe in other categories Denmark – registered
Willian A. Cook Australia Pty, Ltd. Australia – K171625 (2018)
Zhejiang Horizon Medical Technology Co., Ltd. China – K232163 (2024)

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