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Emdyca

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

Gynaecology and fertility treatment instruments - hardware accessories

EMDN code Z12080280

5 manufacturers, 24 models including 24 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 5
  • 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
Cook Vandergrift FDA EU representative : COOK MEDICAL EUROPE LIMITED (Ireland) United States
11 others
 I, IIa 93/42 Website EUDAMED record Report an error
Gynesonics FDA EU representative : Obelis s.a. (Belgium) United States I MDR Website regulatory@gynesonics.com EUDAMED record Report an error
Karlstorz FDA Germany I, IIa MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Medfact FDA Germany I MDR Website office@medfact.eu EUDAMED record Report an error
Memphasys EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia I MDR 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) 13

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
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)
Vitrolife A/S Present in Europe in other categories Denmark ICSI Pipette Biopsy Pipette Holding Pipette Hatching Pipette Handling Pipette Dissection Pipette registered
Coopersurgical, Inc. Present in Europe in other categories United States EZ-Tip EZ-Squeeze EZ-Strip EZ-Grip registered
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
VITROMED GmbH Present in Europe in other categories Germany V-DENUPET K192146 (2020)
Guangzhou PINZHI Medical Device Co., Ltd. China Denudation Pipettes K250838 (2025)
Cook, Inc. United States Cook K151018 (2016)
FUJIFILM IRVINE SCIENTIFIC, INC. – CryoTip® registered
ALLWIN MEDICAL DEVICES, INC. Present in Europe in other categories United States – K261234 (2026)
LIFEGLOBAL GROUP, LLC Present in Europe in other categories United States – K152581 (2016)
Sunlight Medical, Inc. United States – K092554 (2010)

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