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 PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW	5815-150-22	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	605024022	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	493751012	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	492002212	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	596001512	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595512032	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	491501012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	603002022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582002012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	556002012	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7920-010-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582524012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592004012	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	494501812	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8225-010-11	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8217-008-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592512032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582008022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593012012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582010022	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5955-040-32	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	583018012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8222-015-11	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	491751512	FDA UDI	Class II	Active
Scoreflex NC Scoring PTCA Catheter	617-154-1U	FDA UDI	Class III	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8220-015-11	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW	5850-240-12	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594024032	FDA UDI	Class II	Active
Sapphire NC Plus	225-123-2U	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	495001012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	581508012	FDA UDI	Class II	Active
Sapphire NC Plus	250-103-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	554004012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	552012012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582006012	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	492871812	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594015012	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7920-015-11	FDA UDI	Class II	Active
Scoreflex NC Scoring PTCA Catheter	617-104-1U	FDA UDI	Class III	Active
Jade PTA Balloon Dilatation Catheter	607018022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	604002022	FDA UDI	Class II	Active
Jade PTA	L540-40040U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594008022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594508012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8240-018-11	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5935-100-32	EUDAMEDFDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	604024032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	605015022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597004012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592002032	FDA UDI	Class II	Active

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