Manufacturer

Combei

ChinaLegal entities : Shenzhen Combei Technology Co.,Ltd.

Markets : Austria · Bulgaria · France · Germany · Greece · Hungary · Italy · Lithuania · Poland · Romania · Slovenia · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 4 · class II · latest in 2021 · see on the FDA website

EU representative : MedNet EC-REP GmbH (Germany)

2 categories, 10 models including 10 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Non-invasive oscillometric blood pressure gauges	Z1203020501	Acard Ticatrom BP200A，BP116A，BP800A，BP156A，BP136A3 refs Arm Blood Pressure Monitor BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C3 refs Arm Blood Pressure Monitor BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A3 refs Arm blood pressure monitor BP118A ，BP810A，BP102A，BP820A，BPCB0A-2H，BP880A3 refs BP660A 4 others CUFF(22-42cm)3 refs Infrared thermometer NC100（ORO-BABY COLOR）93/42 Wrist blood pressure monitor BP606W，BW 315，BW A45，BW A30，BP608W，BP300W3 refs Wrist blood pressure monitor BP885W，BW 320，BP880W，BPCB0A-2F2 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Thermometers - other	V03010199	Infrared thermometer NC200 (PEMPA T200)93/42	IIa 93/42	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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.