Manufacturer

Shenzhen Creative Industry

ChinaLegal entities : Shenzhen Creative Industry Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Netherlands

EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)

5 categories, 23 models including 23 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Pulse oximeters	Z1203020408	AP-10、PC-68B2 refs Fingertip Oximeter PC-60A93/42 Novama Expert® Ręczny Pulsoksymetr HPOXY, model PC-66A, wariant S1 SP-20、PC-66A2 refs PC-60B1、POD-3、PC-60F、PC-60FW3 refs PC-60B、POD-2、POD-2W3 refs 4 others PC-60D2 PC-60D32 refs PC-60E、PC-60N、PC-60NW3 refs PC-66B、PC-66B1、PC-66B23 refs POD-1、POD-1W2 refs	IIa MDR, 93/42	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	AIVIEW V10、PH10、LeMonitor V10、AIVIEW V12、PH12、LeMonitor V123 refs K10、K12、K153 refs PC-3000、Deluxe-70 PC-900B93/42 PC-900、PC-900PRO 1 other UP-7000、Advance-120	IIb MDR, 93/42	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	AIView VS、LeMonitor VS、MS10、VS103 refs AIView VX、AT10、LeMonitor VX、MT103 refs AP-20 PC-102 PC-303	IIa, IIb MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	PC-80B、CARDIO-B2 refs PC-80D、H6002 refs	IIa MDR	EUDAMED record Report an error
Multi-parameter monitors - medical device software	Z1203020292	AI-ECG Monitor、PC-1000A2 refs	IIb MDR	EUDAMED record Report an error

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