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
Sapphire NC Plus	222-123-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592512022	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8250-010-11	EUDAMEDFDA UDI	Class II	Active
Jade PTA	L540-30015U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	586018012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597008012	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7930-030-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593006012	FDA UDI	Class II	Active
Sapphire II Pro	220-203-5UU	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597006032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582518022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	581512032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594006012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582012012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592001512	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593506012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8245-012-11	EUDAMEDFDA UDI	Class II	Active
Sapphire NC Plus	230-153-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594018022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	551508012	FDA UDI	Class II	Active
Sapphire NC Plus	230-123-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582024022	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5930-240-32	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582008012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606015032	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7925-010-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594512022	FDA UDI	Class II	Active
Teleport Microcatheter	221-15-1000U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	555018012	FDA UDI	Class II	Active
Sapphire II Pro	235-203-5UU	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW	5855-150-12	EUDAMEDFDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8230-018-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553506012	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5925-015-12	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	596015022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592010022	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW	5855-120-22	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585008022	FDA UDI	Class II	Active
Sapphire NC Plus	240-123-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	584002022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582510022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594012022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	584008032	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7912-015-11	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7920-012-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597006012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	583502012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553512012	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5940-060-32	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	586008022	FDA UDI	Class II	Active

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