Question 1

What types of medical devices does Chengdu Daxan Innovative Medical Tech. Co., Ltd. manufacture?

Accepted Answer

Chengdu Daxan Innovative Medical Tech. Co., Ltd. specializes in single-use intermittent urethral drainage catheters made from polyvinyl chloride (PVC) with a hydrophilic coating. These catheters are intended for temporary urinary catheterization in clinical environments, ensuring ease of insertion and use.

Question 2

Where is Chengdu Daxan Innovative Medical Tech. Co., Ltd. based?

Accepted Answer

The company operates from the United States, as indicated in its regulatory documentation. This location is relevant for understanding its manufacturing and compliance framework.

Question 3

Which regulatory registries list the devices manufactured by Chengdu Daxan Innovative Medical Tech. Co., Ltd.?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) system, specifically under the fda_udi registry. This system helps track and identify medical devices for regulatory and clinical purposes.

Question 4

How are the devices produced by Chengdu Daxan Innovative Medical Tech. Co., Ltd. classified under FDA regulations?

Accepted Answer

The company’s intermittent urethral drainage catheters fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Device	Model / Reference	Registries	Class	Status
PVC Hydrophilic Urethral Catheter	H01-14FS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-10WS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-08M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-14W	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-08MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12W	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-18F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-14WS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12WS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-14M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-14MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-08F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-18M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16WS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-10F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-14F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-08FS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-12FS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-10M	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-18MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16W	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16FS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-18FS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-10MS	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-16F	FDA UDI	Class II	Active
PVC Hydrophilic Urethral Catheter	H01-10W	FDA UDI	Class II	Active

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