Manufacturer

Braincare (Beijing) medical device

ChinaLegal entities : Braincare (Beijing) medical device co. LTD

Markets : Ireland

Approvals : EU – class I, IIb

EU representative : NEO HEALTHIES LIMITED (Ireland)

2 categories, 4 models including 4 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Multi-parameter monitors - hardware accessories	Z1203020280	Cerebral blood oxygen sensor BRS-1MR-B、BRS-1-RM、BRS-1MR-C、BRS-1RE-R、BRS-1-RSR、BRS-1RE-RSL、BRS-1-RR、BRS-1RE-RL、BRS-1-RL、BRS-1RE-RXL、BRS-1-RXL、BRS-1RE-RM、BRS-1RE-RSR、BRS-1MR-A、BRS-1-RSL、BRS-1RE-RR、BRS-1-R Tissue oxygen sensor BRS-1-CSL、BRS-1-CR、BRS-1-CL、BRS-1RE-CR、BRS-1RE-CXL、BRS-1RE-CSL、BRS-1RE-CL、BRS-1RE-C、BRS-1RE-CM、BRS-1RE-CSR、BRS-1-C、BRS-1-CSR、BRS-1-CM、BRS-1-CXL Wireless brain blood oxygen monitoring headband BRS-2	IIb MDR	EUDAMED record Report an error
Electroencephalographs	Z12100302	SE-A10-L、SE-A10-N、SE-A11-L、SE-A11-N、SE-P10-L、SE-P10-N、SE-P11-L、SE-P11-N	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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