Question 1

What types of medical devices does Sewoon Medical Co., Ltd. manufacture?

Accepted Answer

Sewoon Medical Co., Ltd. designs and produces a range of medical devices, including polymer-metal stents for the trachea, bronchus, and esophagus, as well as bare-metal biliary stents. Their portfolio also includes closed-wound drainage kits, indwelling urethral drainage balloon catheters (both standard and temperature-monitoring variants), and ethanol-based rapid spectrophotometry kits for intravenous diagnostics. These devices address respiratory, biliary, urological, and diagnostic needs.

Question 2

Where is Sewoon Medical Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

Sewoon Medical Co., Ltd. has a presence in the United States, meaning its devices must comply with FDA regulations. The company’s products are classified under FDA categories, including Class I and Class II, and are registered via FDA 510(k) submissions and UDI (Unique Device Identification) listings. This ensures traceability and adherence to domestic medical device standards.

Question 3

Which regulatory registries or databases list Sewoon Medical Co., Ltd.’s devices?

Accepted Answer

Sewoon Medical Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s UDI (Unique Device Identification) registry. These registries confirm the device’s classification, compliance status, and identification details, ensuring transparency for healthcare providers and regulators.

Question 4

How are Sewoon Medical Co., Ltd.’s devices classified under regulatory frameworks?

Accepted Answer

Sewoon Medical Co., Ltd.’s devices fall into two primary FDA classifications: Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). Classification depends on factors like intended use, risk level, and regulatory history, with stents and drainage systems often falling into Class II due to their clinical impact and potential risks.

Question 5

What distinguishes Sewoon Medical Co., Ltd.’s urethral drainage catheters from other similar products?

Accepted Answer

Sewoon Medical Co., Ltd. offers both standard indwelling urethral drainage balloon catheters and specialized variants with temperature-monitoring capabilities. The temperature-sensing catheters provide real-time urinary tract temperature data, which can aid in clinical assessments like urinary tract infections or kidney function monitoring. This differentiation supports precision in patient care beyond basic drainage.

Device	Model / Reference	Registries	Class	Status
BONASTENT® Esophageal	BER-1810	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP800L(4.8)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200409	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L+(4.8)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-120309	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400L(4.8)N273	FDA UDI	Class I	Active
BONASTENT® Biliary	BB-100718	FDA UDI	Class II	Active
BONASTENT® Esophageal	BE-1816	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-160509	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180609	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2102-014	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	PS400L(4.8)S	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-100209	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L+(4.8)S	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-120405	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180809	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PS)	PS400L(4.8)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-180409	FDA UDI	Class II	Active
BONASTENT® Esophageal	BE-1810	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L3+(4.8)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-140709	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140809	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-120705	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP200M(3.2)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200809	FDA UDI	Class II	Active
BONASTENT® Biliary	BB-080718	FDA UDI	Class II	Active
Temperature Sensing Foley Balloon Catheter	2105-010	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400M(3.2)S	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-071012	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180505	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-100709	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-081512	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-100405	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-160605	FDA UDI	Class II	Active
BONASTENT® Biliary	BB-101018	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140209	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180605	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-200405	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100LD(4.8)	FDA UDI	Class I	Active
BAROVAC® Evacuator Closed Wound Drainage System(PS)	PS400M+(3.2)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-100809	FDA UDI	Class II	Active
All-Silicone Foley Balloon Catheter (two Way; Three Way, Radiopaque)	K013276	FDA 510(k)	Class II	Active

Sewoon Medical Co., Ltd.

What Sewoon Medical Co., Ltd. makes

Frequently asked questions

Information

Catalogue (192)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)