Question 1

What types of medical devices does Hunan Vathin Medical Instrument Co., Ltd manufacture?

Accepted Answer

Hunan Vathin Medical Instrument Co., Ltd specializes in single-use flexible endoscopes, including flexible video cystoscopes, ureteroscopes, and otorhinolaryngoscopes, as well as flexible video bronchosopes. They also produce ureteral introduction sheaths and associated endoscopic video processing and display units, which are used for real-time imaging during medical procedures. These devices are designed to streamline procedures while reducing infection risks associated with reusable equipment.

Question 2

Where is Hunan Vathin Medical Instrument Co., Ltd based, and what regulatory region does it operate in?

Accepted Answer

Hunan Vathin Medical Instrument Co., Ltd is based in the United States. As a manufacturer, it operates under U.S. medical device regulations, ensuring its products comply with applicable standards for safety, performance, and quality. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their regulatory engagement in the U.S. market.

Question 3

Which regulatory registries or databases list Hunan Vathin Medical Instrument Co., Ltd’s devices?

Accepted Answer

Hunan Vathin Medical Instrument Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers, regulators, and patients. Listing in the UDI database is a requirement for Class II devices, which these products fall under.

Question 4

How are Hunan Vathin Medical Instrument Co., Ltd’s devices classified under regulatory standards?

Accepted Answer

Hunan Vathin Medical Instrument Co., Ltd’s devices are classified as Class II under regulatory standards. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. The company’s products, such as single-use endoscopes and associated imaging units, align with this classification due to their role in minimally invasive procedures while maintaining infection control and performance standards.

Device	Model / Reference	Registries	Class	Status
Single-Use Flexible Cystoscope	CY-E2G01R	FDA UDI	Class II	Active
Digital Video Processor	SYS-5100	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1D00	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S2602R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-E2E01R	FDA UDI	Class II	Active
Single-Use Flexible Rhinolaryngoscope	RL-E1E00	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E2600R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1B01R	FDA UDI	Class II	Active
Single-Use flexible Video Bronchoscope	BCV1-02	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E170R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1H01	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1B01	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E2602	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E170	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1A02	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1J00	FDA UDI	Class II	Active
Single-Use Flexible Rhinolaryngoscope	RL-S1E01	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1802	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1D00R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1D01	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E2600	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1E00R	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S2600R	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S2600	FDA UDI	Class II	Active
Single-Use Flexible Rhinolaryngoscope	RL-E1E01	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S180	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1E00	FDA UDI	Class II	Active
Single-Use Flexible Rhinolaryngoscope	RL-S1800	FDA UDI	Class II	Active
Single-Use flexible Video Bronchoscope	BCV1-W2	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1B03	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1B02	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1B00	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1H00R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S2E01	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S170R	FDA UDI	Class II	Active
Single-Use Flexible Rhinolaryngoscope	RL-E1800	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1H00	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1B00R	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1C02	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-E2F01	FDA UDI	Class II	Active
Single-use Ureteral Access Sheath	UA-S1D02	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-E2E01	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S2E01R	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-S2602	FDA UDI	Class II	Active
Single-Use flexible Video Bronchoscope	BCV1-0M2	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1E01R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1J00R	FDA UDI	Class II	Active
Single-use Flexible Ureteroscope	US-E180	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1H01R	FDA UDI	Class II	Active
Single-Use Flexible Cystoscope	CY-S1J01R	FDA UDI	Class II	Active

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