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Emdyca

Instruments for functional explorations and therapeutic interventions

Gastroenterological instruments

EMDN code Z1207

7 manufacturers, 14 models including 13 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 7
  • 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
Covidien FDA EU representative : Medtronic B.V. (Netherlands) United States
1 other
 I, IIa MDR, 93/42 EUDAMED record Report an error
Diversatek Healthcare FDA EU representative : Advena Limited (Malta) United States I, IIa MDR Website sales@diversatekhc.com EUDAMED record Report an error
Laborie FDA EU representative : Medical Measurement Systems B.V. (Netherlands) United States I, IIa MDR EUDAMED record Report an error
Enteralaccesstech FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I 93/42 Website info@enteralaccesstech.com EUDAMED record Report an error
Medica Italy IIb MDR Website EUDAMED record Report an error
Sidam FDA Italy IIa MDR info@sidamit.it EUDAMED record Report an error
THD FDA Italy IIa MDR regulatory@thdlab.com 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) 25

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
H & A Mui Enterprises Inc Canada Mui Scientific Mui Scienific Mui Sicentific MuiScientific registered
Unisensor AG United States UniTip High Resolution Catheter UniTip Catheter pHTip Disposable Catheter K062222 (2007)
Given Imaging , Ltd. Israel Versaflex Bravo Reflux Digitrapper ManoScan ManoView K151086 (2016)
Medical Measurement Systems B.V. Netherlands 2 channel pH antimony, 21 cm spacing, 6.4 Fr 2 channel pH antimony, 15 cm spacing, 6.4 Fr 1 channel pH antimony, Pediatric, 5 Fr 2 channel pH antimony, 10 cm spacing, 6.4 Fr 2 channel pH antimony, 5 cm spacing, 6.4 Fr 1 channel pH antimony, 6.4 Fr K121014 (2012)
Konsyl Pharmaceuticals, Inc. United States Sitzmarks Radiopaque Markers K181750 (2018)
ANX ROBOTICA CORP United States IntraMarX 3D IntraMarX IntraMarX Radiopaque Markers K201106 (2020)
G & J Electronics, Inc. Canada Distender II Barostat K991288 (1999)
Heidelberg Medical Inc – Heidelberg pH Capsule System registered
The Reflux Company United States Restech registered
Chongqing Jinshan Science & Technology (Group) Co., Ltd China alpHaONE registered
Crospon, Ltd. United States EndoFLIP K183072 (2019)
Laborie Medical Technologies Canada ULC – Anorectal Manometry Catheter registered
MEDSPIRA, LLC United States mcompass Anorectal Balloon Expulsion Catheter K252605 (2025)
Medifactia AB Sweden Transit-Pellets K222000 (2023)
Neuraxis, Inc. United States RED registered
ALACER INDUSTRIA ELETRONICA LTDA Brazil – registered
Ankon Medical Technologies (Shanghai) Co., Ltd. United States – registered
BIOTEQUE CORP Taiwan – registered
Demcon Production B.V. Netherlands – registered
Emsere, Inc Netherlands – registered
Mui Scientific Canada – K262621 (2026)
Quipment France – registered
Rose Medical United States – registered
Spectrum Plastics Group (Fermatex Vascular Tech D.B.A Adam S United States – registered
Wilson-Cook Medical, Inc. United States – K160170 (2016)

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