Manufacturer

Sonomed

Poland, United StatesLegal entities : Przedsiębiorstwo Wdrożeniowo-Produkcyjne Sonomed Sp. z o. o., Sonomed, Inc.

Markets : Italy · Poland · Spain · United States

Approvals : EU – class IIa · United States (FDA) – 510(k) : 13 · class I, II · latest in 2017 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

5 categories, 29 models including 29 on the market, 2 countries

Category	EMDN code	Registered models	Class	Contact
Ultrasound scanners - other	Z11040199	MasterVu A MV450093/42 MasterVu B MV560093/42 PacScan Plus 300 A+93/42 PacScan Plus 300 AP+93/42 VuMAX2 refs93/42 12 others VuMAX BA93/42 VuMAX BU93/42 VuMAX BUA93/42 VUMAX UA93/42 VuPad5 refs93/42 VuPad A/B/UBM93/42 VuPad A/B/UBM/P93/42 VuPad AP93/42 VuPad B/UBM93/42 VuPad B/UBM/P93/42 VuPad BP93/42 VuPad UBM/P93/42	IIa 93/42	EUDAMED record Report an error
Blood flow meters	Z12040111	Głowica ultradźwiękowa CW493/42 Głowica ultradźwiękowa CW593/42 Głowica ultradźwiękowa PW293/42 Głowica ultradźwiękowa SPW16 bagnetowa93/42 Głowica ultradźwiękowa SPW16 cewnik93/42 2 others Głowica ultradźwiękowa SPW16 zgięta SPW16 zagięta93/42 MD4-CW8 Kieszonkowy detektor przepływu93/42	IIa 93/42	EUDAMED record Report an error
Blood flow velocimeters	Z12059005	MD4 Kieszonkowy detektor przepływu93/42 UD 48V Zaawansowany Doppler naczyniowy UD48V93/42	IIa 93/42	EUDAMED record Report an error
Foetal heartbeat detectors	Z12080103	Detektor tętna płodu FEDO93/42 Głowica ultradźwiękowa CW293/42	IIa 93/42	EUDAMED record Report an error
Handheld ultrasound scanners	Z11040106	GoVu93/42	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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