Manufacturer

Envisen

ChinaLegal entities : Shenzhen Envisen Industry Co., Ltd.

First countries of placing on the market declared in EUDAMED : Austria, Finland, Germany, Italy, Sweden

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

5 categories, 11 models including 11 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Body temperature monitoring probes - other	V03010299	Disposable Temperature Probe14 refs93/42 Disposable Temperature Probe TGM-1691-75 Reusable Temperature Probe RGS-1492-28093/42 Reusable Temperature Probe RSS-1492-28093/42	IIb MDR, 93/42	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	NIBP Cuff NDD-0106P-20、NDD-0206P-20、NDD-0506P-20、NDD-0606P-20、NDD-0706P-20、NDD-1102P-203 refs NIBP Cuff NDS-1102P-20、NDS-0106P-20、NDS-0206P-20、NDS-0506P-20、NDS-0606P-20、NDS-0706P-20、NDS-0902P-20、NDS-1202P-20、NDS-1302P-20、NDS-1002P-203 refs NIBP Cuff NRS-1102-30	I MDR	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Pulse Oximeter93/42 Pulse Oximeter HandyOxi50093/42	IIb 93/42	EUDAMED record Report an error
Multi-parameter monitors - other	Z1203020299	Medical Cable Assemblies XT-9092-500、XT-9092-300、XT-9093-500、XT-9093-300、XT-9094-300、XT-11494-3003 refs	I MDR	EUDAMED record Report an error
Retractors, backrests, brackets and supports	Y121821	Head Positioning Device QPHPD、QView-P、QView-JS、QView-3、QView-PS、QView-3S3 refs	I MDR	EUDAMED record Report an error

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