Manufacturer

Teleflex

Ireland, United StatesLegal entities : Arrow International LLC (Subsidiary of Teleflex Incorporated), Teleflex Medical

Markets : Belgium · Czechia · France · Germany · Greece · Ireland · Italy · Netherlands · Poland · Portugal · Slovakia · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 125 · PMA : 1 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 478 · Italy 94 · Spain 75 · Czechia 73 · Greece 43 · Portugal 26 · Germany 7 · Poland 6 · Belgium 5 · Slovakia 5 · Netherlands 1

EU representative : Teleflex Medical (Ireland)

Website orders.intl@teleflex.com

7 categories, 26 models including 26 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
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Category	EMDN code	Registered models	Class	Contact
Various instruments for cardiology and cardiac surgery -other	Z12059099	5 Lead Clip Ends AHA For use with AutoCAT 2 IABP IPN92761793/42 5 Lead Clip Ends IEC For use with AutoCAT 2 IABP IPN92761993/42 5 Lead ECG Cable Assembly AHA For use with IABP IPN91585493/42 5 Lead ECG Cable Assembly AHA For use with IABP IPN92760693/42 5 Lead ECG Cable Assembly IEC For use with IABP IPN91585593/42 10 others 5 Lead ECG Cable Assembly IEC For use with IABP IPN92760793/42 5 LEAD ECG CABLE ASSEMBLY IEC IPN00021193/42 5 Lead ECG Main Trunk Cable AHA For use with AutoCAT 2 IABP IPN92761593/42 5 Lead ECG Main Trunk Cable IEC For use with AutoCAT 2 IABP IPN92761693/42 AC3 CONT. EUROPE POWER CORD (16FT/5M) IPN91587193/42 AC3(TM) Australian Power Cord (16 Ft/5M) For use with IABP IPN92760193/42 AC3(TM) Continental Europe Power Cord (16 Ft/5M) For use with IABP IPN92761293/42 AC3(TM) UK Plug Power Cord (16 Ft/5M) For use with IABP IPN92761193/42 Chart Paper 10 per box IPN00023193/42 Chart Paper 10 per box IPN92760893/42	I 93/42	EUDAMED record Report an error
Aortic pumps	Z12059004	AC3 Optimus(TM) IABP IPN00111293/42 AC3 Optimus(TM) IABP IPN00111393/42 AC3 Optimus(TM) IABP IPN91654993/42 AC3 Optimus(TM) IABP IPN91728593/42 AC3 Optimus(TM) IABP IPN91728693/42	IIb 93/42	EUDAMED record Report an error
Surgical navigation instruments - consumables	Z12011485	VPS Rhythm(TM) ECG Accessory Pack with Johans Adapter RHY-100-ECGJ93/42 VPS TipTracker(TM) Stylet Accessory RHY-177-TTSAP93/42	IIa 93/42	EUDAMED record Report an error
Body temperature monitoring probes - other	V03010299	Rectal/Pharyngeal Temperature Sensor	IIa MDR	EUDAMED record Report an error
Electrocardiographs - consumables	Z12050385	Arrow-Johans(TM) ECG Adapter for Right Atrial Electrocardiography (RAECG)	IIa MDR	EUDAMED record Report an error
Laryngoscopes	Z12021003	Rusch EquipLED Reusable Standard Laryngoscope Blade3 refs	I MDR	EUDAMED record Report an error
Surgical navigation system	Z12011401	VPS Rhythm(R) ECG Lead IEC VPS Rhythm Device ECG Lead (1)	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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