Manufacturer

Lumitex

United StatesLegal entities : Lumitex Medical Devices, Inc.

Markets : Bulgaria · Croatia · Cyprus · Czechia · Denmark · Estonia · Finland · France · Germany · Greece · Hungary · Italy · Latvia · Lithuania · Netherlands · Norway · Poland · Portugal · Romania · Slovakia and 4 more countries

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 3 · class I, II · latest in 2012 · see on the FDA website

EU representative : MDSS GmbH (Germany)

Website

2 categories, 103 models including 103 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Paediatric phototherapy equipment	Z12080401	BiliSoft 2.0 PT Systems, Large Pad, Arabic, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Arabic, UK Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Arabic, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Brazilian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Bulgarian, CE Plug93/42 95 others BiliSoft 2.0 PT Systems, Large Pad, Chinese, CCC Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Croatian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Czech, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Danish, Danish Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Dutch, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Dutch, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, Australian Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, Indian Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, South Africa Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, UK Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, UK Plug, Malaysian93/42 BiliSoft 2.0 PT Systems, Large Pad, English, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, English, US Plug, Homecare93/42 BiliSoft 2.0 PT Systems, Large Pad, Estonian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Finnish, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, French, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, French, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, French, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, German, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, German, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Greek, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Hungarian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Indonesian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Italian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Italian, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Japanese, JP Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Kazakh, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Korean, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Latvian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Lithuanian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Norwegian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Polish, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Portuguese, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Romanian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Russian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Serbian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Slovakian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, Italy Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Swedish, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Turkish, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Ukrainian, CE Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Vietnamese, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, UK Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Brazilian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Bulgarian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Chinese, CCC Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Croatian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Czech, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Danish, Danish Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Dutch, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Dutch, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, Austraillian Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, Indian Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, South Africa Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, UK Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, UK Plug, Malaysian93/42 BiliSoft 2.0 PT Systems, Small Pad, English, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, English, US Plug, Homecare93/42 BiliSoft 2.0 PT Systems, Small Pad, Estonian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Finnish, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, French, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, French, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, French, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, German, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, German, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Greek, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Hungarian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Indonesian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Italian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Italian, Swiss Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Japanese, JP Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Kazakh, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Korean, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Latvian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Lithuanian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Norwegian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Polish, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Portuguese, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Romanian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Russian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Serbian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Slovakian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, Italy Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, US Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Swedish, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Turkish, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Ukrainian, CE Plug93/42 BiliSoft 2.0 PT Systems, Small Pad, Vietnamese, US Plug93/42	IIa 93/42	EUDAMED record Report an error
Neonatology instruments - other	Z12080499	BiliSoft 2.0 PT System, Small Pad, Philippines English, US Plug93/42 BiliSoft 2.0 PT Systems, Large Pad, Phillipines English, US Plug93/42 Disposables Pad Covers and Pad Nests Product Family3 refs	I, IIa MDR, 93/42	EUDAMED record Report an error

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