OrbusNeich Medical (Shenzhen) Co., Ltd.

1 Jinkui Road, Futian Free Trade Zone, Guangdong, China, 518038

35 devices* 58 registrations
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Devices

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Showing 1–20 of 35 devices

Device Name US UK CA AU EU
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Jade Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
JADE PLUS Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
JADE PLUS PTA Balloon Dilatation Catheter Registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
JADE PTA Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
JADE PTA BALLOON DILATATION CATHETER Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
JADE PTA (JADE 14 OTW) Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
JADE PTA (JADE 18 OTW) Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
JADE PTA (JADE 18 RX) Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
JADE PTA (JADE 35 OTW) Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Sapphire 3 Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Registered with EU (EUDAMED)
SAPPHIRE 3 CORONARY DILATATION CATHETER Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Sapphire II NC Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
SAPPHIRE II NC CORONARY DILATATION CATHETER Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Sapphire II PRO Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
SAPPHIRE II PRO BALLOON DILATATION CATHETER Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Sapphire II Pro Coronary Dilatation Catheter Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
Sapphire II (RX) Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Sapphire NC 24 Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Registered with EU (EUDAMED)
SAPPHIRE NC 24 CORONARY DILATATION CATHETER Not registered with US (FDA) Registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
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