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Emdyca

Manufacturer

Integralife

Ireland, United StatesLegal entities : Integra LifeSciences (Ireland) Limited, Integra LifeSciences Corporation, Integra LifeSciences Production Corporation

Markets : Belgium · France · Italy · United States

Approvals : EU – class I, IIa, IIb, III · United States (FDA) – 510(k) : 108 · PMA : 7 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Italy 42 · France 2

EU representative : Integra LifeSciences Services (France)

8 categories, 17 models including 17 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Intracranial pressure measuring systems Z12039001
4 others
 IIb, III 93/42 EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other Z12019099 IIa, III 93/42 EUDAMED record Report an error
Brain tissue monitoring systems Z12109006 I MDR EUDAMED record Report an error
Cerebrospinal fluid pressure monitoring systems Z12109003 I MDR EUDAMED record Report an error
Instruments for ultrasonic surgery - consumables Z12010885 I, IIa MDR EUDAMED record Report an error
Instruments for ultrasonic surgery - hardware accessories Z12010880 IIb, III MDR EUDAMED record Report an error
Patient positioning instruments - hardware accessories Z12011280 I MDR EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - other Z129099 IIa 93/42 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.

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