Manufacturer

Unimax Medical Systems

TaiwanLegal entities : Unimax Medical Systems Inc.

Markets : Austria · Belgium · Czechia · Denmark · France · Germany · Greece · Ireland · Italy · Malta · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 7 · class I, II · latest in 2021 · see on the FDA website

EU representative : mdi Europa GmbH (Germany)

Website ra@unimaxmeds.com

5 categories, 46 models including 46 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
Various instruments for general and multidisciplinary surgery - other	Z12019099	Disposable Suction Probe2 refs93/42 High Flow- Insufflation filter FIF00100193/42 High Flow- Insufflation tubing set for Storz Optitherm93/42 High Flow- Insufflation tubing set with 15/22mm round connector93/42 High Flow- Insufflation tubing set with 15mm round connector93/42 31 others High Flow- Insufflation tubing set with click-in adaptor93/42 High Flow- Insufflation tubing set with luer lock FIF23150U93/42 High Flow- Insufflation tubing set with O-ring adaptor FIF23151U93/42 Insufflation tubing set with 15/22mm round connector93/42 Insufflation tubing set with 22mm round connector93/42 Insufflation Tubing Set With Filter- 15mm Connector93/42 Insufflation Tubing Set With Filter- 22mm Connector93/42 Insufflation tubing set with luer lock FIF23150093/42 Insufflation Tubing Set With Luer Lock LM401 / FIF23150593/42 Insufflation Tubing Set With Stryker (Click – IN) Adaptor93/42 Laparoscopic aspiration needle FPBN5335093/42 Monopolar L hook probe for S/I set FSA20533093/42 Monopolar spatula probe for S/I set FSA30533093/42 Probe for Suction Irrigation93/42 Probe for Suction Irrigation FPB10533093/42 Probe for Suction Irrigation FPB10545093/42 Probe for Suction Irrigation FPB11033093/42 Suction & Irrigation Probe 10mm / 33cm93/42 Suction & Irrigation Probe 5mm/45cm93/42 Suction & Irrigation Set 5mm / 33cm Dual Spike93/42 Suction & Irrigation Set 5mm / 45cm Dual Spike93/42 Suction irrigation set93/42 Suction Irrigation Set (Dual Spike)93/42 Suction Irrigation Set (Single Spike)93/42 Suction irrigation set FSI12805C93/42 Suction irrigation set FSI13305C93/42 Suction irrigation set FSI13310C93/42 Suction irrigation set FSI14505C93/42 Suction irrigation set FSI14510C93/42 Suction Irrigation set with L hook FSI63305C93/42 Suction irrigation set with spatula FSI83305C93/42	IIa, IIb 93/42	EUDAMED record Report an error
Surgical smoke evacuation systems	Z12019004	Smoke evacuation system FSE10500093/42 Smoke Evacuation Tubing LM444 / FSE10510393/42 Smoke evacuation tubing with active carton & tower clamp93/42 Smoke evacuation tubing with roller clamp93/42	I, IIa 93/42	EUDAMED record Report an error
Lens cleaning units	Z12029015	Anti fog solution alcohol free2 refs93/42 Anti fog solution for endoscopes93/42 Anti fog solution with alcohol2 refs93/42	IIa 93/42	EUDAMED record Report an error
Surgical medical aspirators	Z120105	DERBY YANKAUER SUCKER4 refs93/42 Yankauer suction probe4 refs93/42	IIa 93/42	EUDAMED record Report an error
Irrigators	Z12019007	Pressure Infusion Cuff 1PPI305002 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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