Manufacturer

Merit

Singapore, United StatesLegal entities : Merit Medical Singapore Pte. Ltd., Merit Medical Systems, Inc.

Markets : Austria · Belgium · France · Germany · Italy · Netherlands · Norway · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 194 · PMA : 1 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 335 · Spain 30 · Sweden 23 · Italy 15 · Portugal 15 · Belgium 1 · Germany 1 · Norway 1

EU representative : Merit Medical Ireland Ltd (Ireland)

Website udiadmin@merit.com

4 categories, 69 models including 69 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
Angiography tube supports	Z11039019	Excite™93/42 High Pressure Tubing HP5201E/A93/42 High Pressure Tubing HP5300E/A93/42 High Pressure Tubing HP5301E/A93/42 High Pressure Tubing HP5480E/A93/42 46 others High Pressure Tubing HP5481E/A93/42 High Pressure Tubing HP9100E/A93/42 High Pressure Tubing HP9101E/A93/42 High Pressure Tubing HP9200E/A93/42 High Pressure Tubing HP9201E/A93/42 High Pressure Tubing HP9300E/A93/42 High Pressure Tubing HP9301E/A93/42 High Pressure Tubing HP9480E/A93/42 High Pressure Tubing HP9720E/A93/42 High Pressure Tubing HP9721E/A93/42 High Pressure Tubing HPC201E/A93/42 High Pressure Tubing HPC301E/A93/42 High Pressure Tubing HPC391E/A93/42 High Pressure Tubing HPC481E/A93/42 High Pressure Tubing HPC591E/A93/42 High Pressure Tubing HPC721E/A93/42 High Pressure Tubing HPF201E/A93/42 High Pressure Tubing HPF201E/B93/42 High Pressure Tubing HPF301E93/42 High Pressure Tubing HPF301E/B93/42 High Pressure Tubing HPF481E/A93/42 High Pressure Tubing HPF481E/B93/42 High Pressure Tubing HPF721E93/42 High Pressure Tubing HPT101E/A93/42 High Pressure Tubing HPT200E/A93/42 High Pressure Tubing HPT201E/A93/42 High Pressure Tubing HPT300E/A93/42 High Pressure Tubing HPT301E/A93/42 High Pressure Tubing HPT481E/A93/42 High Pressure Tubing HPT591E/A93/42 High Pressure Tubing, Keep™16 refs93/42 Pressure Monitor Tubing PM6012/A93/42 Pressure Monitor Tubing PM602493/42 Pressure Monitor Tubing PM6024/A93/42 Pressure Monitor Tubing PM6036/A93/42 Pressure Monitor Tubing PM6048/A93/42 Pressure Monitor Tubing PM606093/42 Pressure Monitor Tubing PM609693/42 Pressure Monitor Tubing PM6096/A93/42 Pressure Monitor Tubing PM6124/B93/42 Pressure Monitor Tubing PM6136/A93/42 Pressure Monitor Tubing PM6160/A93/42 Pressure Monitor Tubing PM6172-R/A93/42 Pressure Monitor Tubing PM6172/A93/42 Pressure Monitor Tubing PM619693/42 Pressure Monitor Tubing PMT (Pressure Monitoring Tubing)93/42	IIa, IIb 93/42	EUDAMED record Report an error
Invasive blood pressure monitoring instruments	Z1203020301	Clipper™3 refs Critikit™5 refs93/42 Floswitch™93/42 Merit Medical®73 refs Merit Medical® Initial Release93/42 10 others Merit Medical® Safedraw™2 refs93/42 Meritrans DTXPlus®136 refs93/42 Meritrans DTXPlus® 1088445043562293/42 Meritrans®3 refs93/42 Meritrans® Initial Release8 refs93/42 R.O.S.E™93/42 Safedraw™129 refs93/42 Safedraw™ Meritrans DTXPlus®10 refs93/42 TRAM®5 refs93/42 TRAM®P8 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Syringe pumps	Z12030302	basixCOMPAK™27 refs93/42 basixTOUCH™4 refs93/42	I, IIa 93/42	EUDAMED record Report an error
Cardiac output measurement instruments - hardware accessories	Z12050580	Merit Medical®5 refs	I MDR, 93/42	EUDAMED record Report an error

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