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	582002032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592524012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582512012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8245-015-11	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5925-300-32	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553010012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	603006022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	594012012	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8227-018-11	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606010032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	583508022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582515012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	591524022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595508022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	605010012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	607018032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	595001522	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606004012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585008032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553518012	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	603004032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582524032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585018032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592012032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	592510022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585002032	FDA UDI	Class II	Active
Sapphire NC 24 Coronary Dilatation Catheter	493002212	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	593524032	FDA UDI	Class II	Active
Jade PTA	L540-60120U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	585024022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582004032	FDA UDI	Class II	Active
Jade PTA	L540-40080U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	553006012	FDA UDI	Class II	Active
Sapphire II Pro	220-103-5UU	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	597001532	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	584012022	FDA UDI	Class II	Active
Sapphire II Pro	227-103-5UU	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606006032	FDA UDI	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW	5940-040-32	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7930-010-11	FDA UDI	Class II	Active
Sapphire NC Plus	232-103-2U	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	581518032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	555001512	FDA UDI	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	8227-015-11	FDA UDI	Class II	Active
Sapphire NC Plus	225-153-2U	FDA UDI	Class II	Active
Scoreflex NC Scoring PTCA Catheter	625-204-1U	FDA UDI	Class III	Active
Jade PTA Balloon Dilatation Catheter	607008032	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	606002022	FDA UDI	Class II	Active
Jade PTA Balloon Dilatation Catheter	582018012	FDA UDI	Class II	Active
Sapphire ULTRA Coronary Dilatation Catheter	7935-020-11	FDA UDI	Class II	Active

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