Manufacturer

Baxter

Germany, SwitzerlandLegal entities : Baxter Healthcare SA, Baxter Medical Systems GmbH + Co. KG

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Greece · Ireland · Italy · Norway · Poland · Spain · Sweden · United States

Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 644 · PMA : 5 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 134 · Spain 37 · Italy 32 · Germany 22 · Sweden 5 · Austria 4 · Denmark 4 · Poland 3 · Norway 2 · Belgium 1 · Finland 1

EU representative : Baxter Deutschland GmbH (Germany)

Website

13 categories, 37 models including 37 on the market, 2 countries

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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
Patient positioning instruments - hardware accessories	Z12011280	Adapter X-RAY 3-joint narrow3 refs Anaesthesia screen3 refs Arm holder 450 for lateral position3 refs Arm safety strap with locking clamp3 refs Cable remote control TS30003 refs 10 others Carbon 450 H3 refs Carbon Pelvic Extension Set H3 refs Clamp basic3 refs Extension Section Paediatric H Back Section PST5003 refs Extension section Paediatrics T3 refs Iliac Roll Lateral Supp. Spine Set H2 refs Knee support left3 refs Leg Section X-Ray spread joint H3 refs Pad protection for bridge WILSON2 refs Pelvic extension H V3 refs	I MDR	EUDAMED record Report an error
Operating tables	Z12011202	Adapter counter traction post3 refs Operating table TruSystem 7000 U3 refs Pad 215x100 PST 300 Pad3 refs PST 300L PST 300 Mobile Operating Table3 refs PST 500 PST5002 refs 1 other TruSystem 7500	I MDR	EUDAMED record Report an error
Fixed scialytic lamps	Z12010701	Helux Pro Ceiling Duo3 refs TruLight 1000 / Mobile TruLight 1000 - Examination Light3 refs TruLight 5000 / 3000 Ceiling Duo TruLight 5000 / 3000 - Surgical light3 refs	I MDR	EUDAMED record Report an error
Hanging units for the operating room and intensive care	Z129007	FCS 300 Electro Cube FCS 500 Ceiling Carrier HL Solo/TanPrep3 refs FCS 700 Ceiling Supply Unit Solo/TanPrep2 refs	I, IIb MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	4K Camera & 4K Refreshing Unit2 refs TruVidia HD 2000	I MDR	EUDAMED record Report an error
Haemofiltration equipment	Z12090301	PrisMax 95572593/42	IIb 93/42	EUDAMED record Report an error
Infusion instruments - software accessories	Z12030382	DOSE IQ SAFETY SOFTWARE	IIb MDR	EUDAMED record Report an error
Infusion pumps	Z12030301	EVO IQ3 refs	IIb MDR	EUDAMED record Report an error
Medical support equipment - accessories	V0880	EVO IQ3 refs	I MDR	EUDAMED record Report an error
Scialytic lamp lighting systems - other	Z12010799	Pre-Install Set Helux Pro3 refs	I MDR	EUDAMED record Report an error
Syringe pumps	Z12030302	EVO IQ3 refs	IIb MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - hardware accessories	Z119080	Positioner for X-ray cassettes X-Ray Cassette Handling PST5003 refs	I MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	VidiaPort Ceiling Duo3 refs	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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