Manufacturer

Biomedical Instruments

ChinaLegal entities : Biomedical Instruments Co., Ltd.

Markets : Austria · Germany · Ireland · Italy · Poland · Portugal

Approvals : EU – class I, IIa

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

5 categories, 15 models including 15 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
ECG holter recorders	Z12050403	BI660093/42 BI680093/42 BI910093/42 BI9800TL+93/42 BI990093/42 1 other Holter System BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C3 refs	IIa MDR, 93/42	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	PC ECG BI 12A, BI 12C, BI 12D3 refs TeleECG-12A93/42 TeleECG-12C93/42 TeleECG-12D93/42	IIa MDR, 93/42	EUDAMED record Report an error
Blood pressure holter recorders	Z12050404	BI500093/42 BI5000B93/42	IIa 93/42	EUDAMED record Report an error
Holter system instruments for cardiovascular parameters - consumables	Z12050485	ECG Patient Cable PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E493 refs Wearable ECG Sensor PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F3 refs	I MDR	EUDAMED record Report an error
Non-invasive blood pressure monitoring instruments	Z1203020302	Ambulatory Blood Pressure System BP60B	IIa 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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