Q: What types of medical devices does Shinva Ande Healthcare Apparatus Co., Ltd. manufacture?

Shinva Ande Healthcare Apparatus Co., Ltd. specializes in two primary device types: electronic gravity infusion controller administration sets and disposable peripheral intravenous cannulas. Their infusion sets are designed for single-use administration of intravenous fluids, while the IV catheters provide venous access for fluid delivery or blood sampling in clinical environments.

Question 1

What types of medical devices does Shinva Ande Healthcare Apparatus Co., Ltd. manufacture?

Accepted Answer

Shinva Ande Healthcare Apparatus Co., Ltd. manufactures single-use infusion sets designed for electronic gravity infusion controllers and disposable peripheral intravenous catheters. These products are intended for intravenous fluid administration and venous access in clinical settings.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer 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 Shinva Ande Healthcare Apparatus Co., Ltd. based?

Accepted Answer

The company is headquartered in the United States. This location is relevant for regulatory compliance and reporting, as their devices are subject to FDA oversight.

Question 3

Which regulatory registries list Shinva Ande Healthcare Apparatus Co., Ltd.’s devices?

Accepted Answer

The company’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track Class II medical devices to ensure traceability and compliance with U.S. regulations.

Question 4

How are Shinva Ande Healthcare Apparatus Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

All of Shinva Ande Healthcare Apparatus Co., Ltd.’s listed devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Infusion Set for Single Use	AD0102	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0201	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0302	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0401	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0101	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0502	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0501	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0301	FDA UDI	Class II	Active
Disposable IV Catheter	IVC09-18	FDA UDI	Class II	Active
Disposable IV Catheter	IVC07-18	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0202	FDA UDI	Class II	Active
Infusion Set for Single Use	AD0402	FDA UDI	Class II	Active
Closed System Transfer Device	K201460	FDA 510(k)	Class II	Active
Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles	K211484	FDA 510(k)	Class II	Active
Disposable Enteral Feeding Syringe with Enfit Connector	K193657	FDA 510(k)	Class II	Active
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization	K220057	FDA 510(k)	Class II	Active
Disposable IV catheter	K202060	FDA 510(k)	Class II	Active
Infusion Set for Single Use	K162601	FDA 510(k)	Class II	Active

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