Q: What types of medical devices does OrbusNeich Medical (ShenZhen) Co., Ltd. manufacture?

OrbusNeich Medical (ShenZhen) Co., Ltd. specializes in angioplasty balloon catheters and vascular microcatheters. Their primary focus is on devices used for treating narrowed or blocked blood vessels, including peripheral and coronary angioplasty balloon catheters. These include basic balloon catheters, cutting/scoring balloon catheters (like the Scoreflex NC), and vascular microcatheters designed for precise delivery in smaller vessels. These devices are intended for interventional cardiology and peripheral vascular procedures.

Question 1

What types of medical devices does OrbusNeich Medical (ShenZhen) Co., Ltd. manufacture?

Accepted Answer

OrbusNeich Medical (ShenZhen) Co., Ltd. manufactures peripheral and coronary angioplasty balloon catheters, including basic and cutting/scoring types, as well as vascular microcatheters. Specific products include the Jade PTA Balloon Dilatation Catheter, Jade Plus PTA Balloon Dilatation Catheter, and Scoreflex NC Scoring PTCA Catheter.

The company's devices are classified as Class II and Class III medical devices and are listed in the FDA's Unique Device Identification (UDI) system. OrbusNeich Medical (ShenZhen) Co., Ltd. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is OrbusNeich Medical (ShenZhen) Co., Ltd. based?

Accepted Answer

OrbusNeich Medical (ShenZhen) Co., Ltd. is based in the United States. While the company name includes 'ShenZhen,' the operational headquarters and regulatory presence are established in the U.S., where their devices are developed, manufactured, and distributed.

Question 3

Which regulatory registries list OrbusNeich Medical (ShenZhen) Co., Ltd.'s devices?

Accepted Answer

OrbusNeich Medical (ShenZhen) Co., Ltd.'s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency of their medical devices, allowing healthcare providers and regulators to identify and track specific products like the Jade PTA Balloon Dilatation Catheter or Scoreflex NC Scoring PTCA Catheter.

Question 4

How are OrbusNeich Medical (ShenZhen) Co., Ltd.'s devices classified under medical device regulations?

Accepted Answer

OrbusNeich Medical (ShenZhen) Co., Ltd.'s devices fall into two primary regulatory classes: Class II and Class III. Class II devices, such as many of their peripheral and coronary angioplasty balloon catheters, generally pose moderate risk and require special controls to ensure safety and effectiveness. Class III devices, which include certain cutting/scoring balloon catheters, are higher risk and typically require pre-market approval due to their potential life-supporting or life-sustaining functions or use in controlling a disease or condition.

Device	Model / Reference	Registries	Class	Status
Jade PTA Balloon Dilatation Catheter	593518022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592502012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	554508012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606008032	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW	5860-240-22	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	554504012	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5935-240-32	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5955-015-12	EUDAMEDFDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593024022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592002012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595015032	FDA UDI	Class II	Active
Scoreflex NC Scoring PTCA Catheter	617-204-1U	FDA UDI	Class III	Active
Jade PTA Balloon Dilatation Catheter	606024032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	581504032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	584024012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597015032	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5935-020-32	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	583518022	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8232-010-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593512032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	552004012	FDA UDI	Class II	Active
Sapphire NC Plus	250-083-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	605015012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593006022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	586004012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597008022	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5940-100-32	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	495000812	FDA UDI	Class II	Active
Jade PTA	L540-30120U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593010012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8225-012-11	FDA UDI	Class II	Active
Jade PTA	L540-35120U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585012022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	556006012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592001522	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	604015022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593515022	FDA UDI	Class II	Active
Teleport Microcatheter	220-15-1000U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606015022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592018032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595018012	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	493252612	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595004032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593002012	FDA UDI	Class II	Active
Jade PTA	L540-60080U	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8220-018-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595010012	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	494002212	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553012012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8245-008-11	FDA UDI	Class II	Active

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