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Emdyca

Instruments for functional explorations and therapeutic interventionsGastroenterological instruments

Gastric pH monitor

EMDN code Z120704

3 manufacturers, 4 models including 4 on the market, 2 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
Diversatek Healthcare FDA EU representative : Advena Limited (Malta) United States I, IIa MDR Website sales@diversatekhc.com 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
Laborie FDA EU representative : Medical Measurement Systems B.V. (Netherlands) United States I MDR 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) 6

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
Given Imaging , Ltd. Israel Versaflex Bravo Reflux Digitrapper K102543 (2010)
Heidelberg Medical Inc – Heidelberg pH Capsule System registered
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 registered
The Reflux Company United States Restech registered
Chongqing Jinshan Science & Technology (Group) Co., Ltd China alpHaONE registered
ALACER INDUSTRIA ELETRONICA LTDA Brazil – registered

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