Manufacturer

Ardo medical

SwitzerlandLegal entities : Ardo medical AG

Markets : Germany · Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 6 · class I, II · latest in 2023 · see on the FDA website

Public contracts won : Germany 1

EU representative : ARDO medical GmbH (Germany)

4 categories, 17 models including 14 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Breast pumps	Z12080303	AMARYLL START2 refs93/42 Ardo Alyssa9 refs93/42 Ardo Alyssa Conversion Kit93/42 Ardo Bellis3 refs93/42 Calypso2 refs93/42 7 others Calypso Conversion Kit93/42 CALYPSO DOUBLE PLUS2 refs93/42 CALYPSO PUMP UNIT93/42 CALYPSO-TO-GO93/42 CARUM2 refs93/42 CARUM BATTERY2 refs93/42 AMARYLL93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Various childbirth support and maternal assistance instruments - consumables	Z12080385	DOUBLE PUMPSET2 refs93/42 SINGLE PUMPSET2 refs93/42	IIa 93/42	EUDAMED record Report an error
Surgical medical aspirators	Z120105	Master5 refs Senator Low Vacuum93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Various childbirth support and maternal assistance instruments - other No model still on the market	Z12080399	Ardo Natal Support2 refs (no longer marketed)	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.

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