Manufacturer

Orantech

ChinaLegal entities : Orantech Inc.

Markets : Austria · Denmark · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 5 · class I, II · latest in 2019 · see on the FDA website

EU representative : Medten EU ApS (Denmark)

Website

5 categories, 296 models including 296 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Temperature monitoring cutaneous probes	V03010201	Disposable Temperature Probe TSD-AT02-GS1593/42 Temperature probe TS-AS-AG3093/42 Temperature probe TS-AS-AS1593/42 Temperature probe TS-AS-AS3093/42 Temperature probe TS-AS-PS1593/42 189 others Temperature probe TS-AS-PS3093/42 Temperature probe TS-AT-PS1593/42 Temperature probe TS-AT-PS3093/42 Temperature probe TS-AT01-PS1593/42 Temperature probe TS-BE01-AS1593/42 Temperature probe TS-BE01-PS1593/42 Temperature probe TS-BE02-AS1593/42 Temperature probe TS-BE02-PS1593/42 Temperature probe TS-BE03-AS2093/42 Temperature probe TS-BE04-PS1593/42 Temperature probe TS-BLT-AG3093/42 Temperature probe TS-BLT-AS3093/42 Temperature probe TS-BLT-PG3093/42 Temperature probe TS-BLT-PS3093/42 Temperature probe TS-BT-PS1593/42 Temperature probe TS-CM-AG3093/42 Temperature probe TS-CM-AS3093/42 Temperature probe TS-CM01-AG3093/42 Temperature probe TS-CM01-AS3093/42 Temperature probe TS-CM01-PG3093/42 Temperature probe TS-CM01-PS3093/42 Temperature probe TS-CM02-PS3093/42 Temperature probe TS-CM03-PS1093/42 Temperature probe TS-DG-AG1593/42 Temperature probe TS-DG-AG3093/42 Temperature probe TS-DG-AS1593/42 Temperature probe TS-DG-AS3093/42 Temperature probe TS-DG-PG1593/42 Temperature probe TS-DG-PG3093/42 Temperature probe TS-DG-PS1593/42 Temperature probe TS-DG-PS3093/42 Temperature probe TS-DGA-PS1593/42 Temperature probe TS-DGA-PS3093/42 Temperature probe TS-DGB-PS1593/42 Temperature probe TS-DGC-PS1593/42 Temperature probe TS-DGC-PS3093/42 Temperature probe TS-DGD-PS3093/42 Temperature probe TS-DSA-PS1593/42 Temperature probe TS-DSB-PS1593/42 Temperature probe TS-DVA-PS1593/42 Temperature probe TS-DVB-PS1593/42 Temperature probe TS-DVC-PS1593/42 Temperature probe TS-ED-AG3093/42 Temperature probe TS-ED-AS3093/42 Temperature probe TS-ED-PG3093/42 Temperature probe TS-ED-PS3093/42 Temperature probe TS-EDA-AG3093/42 Temperature probe TS-EDA-AS3093/42 Temperature probe TS-EDA-PS3093/42 Temperature probe TS-FA-PS1593/42 Temperature probe TS-FA-PS3093/42 Temperature probe TS-FP01-AS3093/42 Temperature probe TS-FP01-PS3093/42 Temperature probe TS-FP02-1393/42 Temperature probe TS-IFN-AG3093/42 Temperature probe TS-IFN-AS3093/42 Temperature probe TS-IFN-PG3093/42 Temperature probe TS-IFN-PS3093/42 Temperature probe TS-JS-PS1593/42 Temperature probe TS-MQ-AG3093/42 Temperature probe TS-MQ-AS3093/42 Temperature probe TS-MQ-PG3093/42 Temperature probe TS-MQ-PS3093/42 Temperature probe TS-MRA-AG3093/42 Temperature probe TS-MRA-AS3093/42 Temperature probe TS-MRA-AS6093/42 Temperature probe TS-MRA-PG3093/42 Temperature probe TS-MRA-PS3093/42 Temperature probe TS-MRB-AG3093/42 Temperature probe TS-MRB-AS3093/42 Temperature probe TS-MRB-PG3093/42 Temperature probe TS-MRB-PS3093/42 Temperature probe TS-OH-PS1593/42 Temperature probe TS-OH-PS3093/42 Temperature probe TS-OHA-PS1593/42 Temperature probe TS-OHA-PS3093/42 Temperature probe TS-P63SB-AG3093/42 Temperature probe TS-P63SB-AS3093/42 Temperature probe TS-P63SB-PG3093/42 Temperature probe TS-P63SB-PS3093/42 Temperature probe TS-PG-PG3093/42 Temperature probe TS-PH-AG3093/42 Temperature probe TS-PH-AS3093/42 Temperature probe TS-PH-AS4093/42 Temperature probe TS-PH-AS7593/42 Temperature probe TS-PH-PG3093/42 Temperature probe TS-PH-PS3093/42 Temperature probe TS-R10-AG3093/42 Temperature probe TS-R10-AS3093/42 Temperature probe TS-R10-PG3093/42 Temperature probe TS-R10-PS3093/42 Temperature probe TS-R10S-AG3093/42 Temperature probe TS-R10S-AS3093/42 Temperature probe TS-R20-AG3093/42 Temperature probe TS-R20-AS3093/42 Temperature probe TS-R20-PG3093/42 Temperature probe TS-R20-PS3093/42 Temperature probe TS-SD01-PS1693/42 Temperature probe TS-SD02-PS1693/42 Temperature probe TS-SL-AG3093/42 Temperature probe TS-SL-AS3093/42 Temperature probe TS-SL-PG3093/42 Temperature probe TS-SL-PS3093/42 Temperature probe TS-SW-AG3093/42 Temperature probe TS-SW-AS3093/42 Temperature probe TS-SW-PG3093/42 Temperature probe TS-SW-PS3093/42 Temperature probe TS-TR-AG3093/42 Temperature probe TS-TR-AS3093/42 Temperature probe TS-TR-PG3093/42 Temperature probe TS-TR-PS3093/42 Temperature probe TS-Y400-AG3093/42 Temperature probe TS-Y400-AS3093/42 Temperature probe TS-Y400-PG3093/42 Temperature probe TS-Y400-PS3093/42 Temperature probe TS-Y400S-AG3093/42 Temperature probe TS-Y400S-AS3093/42 Temperature probe TS-Y400S-PG3093/42 Temperature probe TS-Y400S-PS3093/42 Temperature probe TS-Y700-AG3093/42 Temperature probe TS-Y700-AS3093/42 Temperature probe TS-Y700-PG3093/42 Temperature probe TS-Y700-PS3093/42 Temperature probe TS-YM01-PS1593/42 Temperature probe TSD-AS-GS1593/42 Temperature probe TSD-AT-GS1593/42 Temperature probe TSD-AT01-GS1593/42 Temperature probe TSD-BLT-GS3093/42 Temperature probe TSD-DG-AG3093/42 Temperature probe TSD-DG-GS3093/42 Temperature probe TSD-DGA-GS1593/42 Temperature probe TSD-DGB-GS1593/42 Temperature probe TSD-DGB-GS3093/42 Temperature probe TSD-DGC-GS1593/42 Temperature probe TSD-DGD-GS1593/42 Temperature probe TSD-DVA-GS1593/42 Temperature probe TSD-DVB-GS1593/42 Temperature probe TSD-DVC-GS1593/42 Temperature probe TSD-IFN-AG3093/42 Temperature probe TSD-IFN-GS3093/42 Temperature probe TSD-JS-GS1593/42 Temperature probe TSD-MQ-AG3093/42 Temperature probe TSD-MQ-GS3093/42 Temperature probe TSD-MRA-AG3093/42 Temperature probe TSD-MRA-GS3093/42 Temperature probe TSD-MRB-AG3093/42 Temperature probe TSD-MRB-GS3093/42 Temperature probe TSD-OH-GS1593/42 Temperature probe TSD-OH-GS3093/42 Temperature probe TSD-OHA-GS0993/42 Temperature probe TSD-OHA-GS1593/42 Temperature probe TSD-OHA-GS3093/42 Temperature probe TSD-PH-AG3093/42 Temperature probe TSD-PH-GS3093/42 Temperature probe TSD-PM-AG0993/42 Temperature probe TSD-PM-GS0993/42 Temperature probe TSD-PM-LAG0993/42 Temperature probe TSD-PM-PG0993/42 Temperature probe TSD-R10-AG3093/42 Temperature probe TSD-R10-GS3093/42 Temperature probe TSD-R20-AG3093/42 Temperature probe TSD-R20-GS3093/42 Temperature probe TSD-SL-AG3093/42 Temperature probe TSD-SL-GS3093/42 Temperature probe TSD-SW-AG3093/42 Temperature probe TSD-SW-GS3093/42 Temperature probe TSD-TR-AG3093/42 Temperature probe TSD-TR-GS3093/42 Temperature probe TSD-Y400-AG3093/42 Temperature probe TSD-Y400-GS3093/42 Temperature probe TSD-YSI-AG0993/42 Temperature probe TSD-YSI-GS0993/42 Temperature probe TSD-YSI-PG0993/42 Temperature probe TSQ-AR01-OB93/42 Temperature probe TSQ-AR01-OB-S93/42 Temperature probe TSQ-AR01-RR93/42 Temperature probe TSQ-AR01-RR-S93/42 Temperature probe TSQ-AR02-OB93/42 Temperature probe TSQ-AR02-OB-S93/42 Temperature probe TSQ-AR02-RR93/42 Temperature probe TSQ-AR02-RR-S93/42 Temperature probe TSQ-GE01-OB93/42 Temperature probe TSQ-GE01-RR93/42 Temperature probe TSQ-MR01-OB93/42 Temperature probe TSQ-MR01-RR93/42 Temperature probe TSQ-WA01-OB93/42 Temperature probe TSQ-WA01-OB-S93/42 Temperature probe TSQ-WA01-RR93/42 Temperature probe TSQ-WA01-RR-S93/42	IIa, IIb 93/42	EUDAMED record Report an error
Foetal monitors	Z12080101	TOCO Fetal transducer FTC-AL0193/42 TOCO Fetal transducer FTC-BA0193/42 TOCO Fetal transducer FTC-BC0193/42 TOCO Fetal transducer FTC-BC0293/42 TOCO Fetal transducer FTC-BL0193/42 85 others TOCO Fetal transducer FTC-BN0193/42 TOCO Fetal transducer FTC-BN0293/42 TOCO Fetal transducer FTC-BT0193/42 TOCO Fetal transducer FTC-CM0193/42 TOCO Fetal transducer FTC-CM0393/42 TOCO Fetal transducer FTC-CM0593/42 TOCO Fetal transducer FTC-ED0293/42 TOCO Fetal transducer FTC-GD0193/42 TOCO Fetal transducer FTC-GD0393/42 TOCO Fetal transducer FTC-GD0593/42 TOCO Fetal transducer FTC-GE0193/42 TOCO Fetal transducer FTC-GE0293/42 TOCO Fetal transducer FTC-GE02S93/42 TOCO Fetal transducer FTC-GE1293/42 TOCO Fetal transducer FTC-JP0193/42 TOCO Fetal transducer FTC-LK0193/42 TOCO Fetal transducer FTC-NM0193/42 TOCO Fetal transducer FTC-NT0193/42 TOCO Fetal transducer FTC-PH0193/42 TOCO Fetal transducer FTC-SC0193/42 TOCO Fetal transducer FTC-SC01-2093/42 TOCO Fetal transducer FTC-SC0293/42 TOCO Fetal transducer FTC-SL0193/42 TOCO Fetal transducer FTC-SL0293/42 TOCO Fetal transducer FTC-SL0393/42 TOCO Fetal transducer FTC-SU0193/42 Ultrasound Fetal transducer FUS-AL0193/42 Ultrasound Fetal transducer FUS-AL0293/42 Ultrasound Fetal transducer FUS-AL0393/42 Ultrasound Fetal transducer FUS-BA0193/42 Ultrasound Fetal transducer FUS-BC0193/42 Ultrasound Fetal transducer FUS-BC0293/42 Ultrasound Fetal transducer FUS-BL0193/42 Ultrasound Fetal transducer FUS-BN0193/42 Ultrasound Fetal transducer FUS-BN0293/42 Ultrasound Fetal transducer FUS-BT0193/42 Ultrasound Fetal transducer FUS-CM0193/42 Ultrasound Fetal transducer FUS-CM0293/42 Ultrasound Fetal transducer FUS-CM0393/42 Ultrasound Fetal transducer FUS-CM0493/42 Ultrasound Fetal transducer FUS-CM0593/42 Ultrasound Fetal transducer FUS-CM0693/42 Ultrasound Fetal transducer FUS-ED0193/42 Ultrasound Fetal transducer FUS-ED0293/42 Ultrasound Fetal transducer FUS-ED0393/42 Ultrasound Fetal transducer FUS-GD0193/42 Ultrasound Fetal transducer FUS-GD0293/42 Ultrasound Fetal transducer FUS-GD0493/42 Ultrasound Fetal transducer FUS-GD0593/42 Ultrasound Fetal transducer FUS-GE0193/42 Ultrasound Fetal transducer FUS-GE0293/42 Ultrasound Fetal transducer FUS-GE02S93/42 Ultrasound Fetal transducer FUS-GE0393/42 Ultrasound Fetal transducer FUS-GE1293/42 Ultrasound Fetal transducer FUS-GM0193/42 Ultrasound Fetal transducer FUS-JP0193/42 Ultrasound Fetal transducer FUS-JP0293/42 Ultrasound Fetal transducer FUS-LK0193/42 Ultrasound Fetal transducer FUS-NM0193/42 Ultrasound Fetal transducer FUS-NT0193/42 Ultrasound Fetal transducer FUS-NT0293/42 Ultrasound Fetal transducer FUS-PA0193/42 Ultrasound Fetal transducer FUS-PH0193/42 Ultrasound Fetal transducer FUS-PH0293/42 Ultrasound Fetal transducer FUS-SC0193/42 Ultrasound Fetal transducer FUS-SC0293/42 Ultrasound Fetal transducer FUS-SC0393/42 Ultrasound Fetal transducer FUS-SC0493/42 Ultrasound Fetal transducer FUS-SC04-2093/42 Ultrasound Fetal transducer FUS-SC0593/42 Ultrasound Fetal transducer FUS-SL0193/42 Ultrasound Fetal transducer FUS-SL0293/42 Ultrasound Fetal transducer FUS-SL0393/42 Ultrasound Fetal transducer FUS-SU0193/42 Ultrasound Fetal transducer FUS-TY0193/42 Ultrasound Fetal transducer FUSTC-BA0293/42 Ultrasound Fetal transducer FUSTC-CM0693/42 Ultrasound Fetal transducer FUSTC-CT0193/42 Ultrasound Fetal transducer FUSTC-CT0293/42 Ultrasound Fetal transducer FUSTC-GD0193/42 Ultrasound Fetal transducer FUSTC-GD0293/42 Ultrasound Fetal transducer FUSTC-GD0393/42 Ultrasound Fetal transducer FUSTC-JP0193/42 Ultrasound Fetal transducer FUSTC-LK0193/42 Ultrasound Fetal transducer FUSTC-TY0193/42	IIa, IIb 93/42	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	Cardiac output cables COCA-BLT01-013 refs ECG Leaderwires3 refs IBP Adapter Cable3 refs NIBP Air Hose3 refs NIBP cuf3 refs 3 others Patient Cable BISA-3F01-303 refs SpO2 Adapter cable3 refs Temperature Adapter cable TA-AT-AT033 refs	I MDR	EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - consumables	Z1203019085	DRAIN, TEE3 refs Fitting/Adapters3 refs Temperature flow probe TSF-FP01-123 refs	I MDR	EUDAMED record Report an error
Prenatal diagnostic instruments - consumables	Z12080185	DECG Legplate Adapter Cables3 refs	I MDR	EUDAMED record Report an error

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