Question 1

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

Accepted Answer

Innovex Medical Co., Ltd. specializes in devices primarily used in urological procedures. Their portfolio includes ureteral introduction sheaths, which assist in accessing the ureter, and ureteral stents, which help maintain patency of the ureter. Additionally, they produce irrigation tubing sets, which are used for flushing and cleaning during surgical or diagnostic interventions.

Question 2

Where is Innovex Medical Co., Ltd. based?

Accepted Answer

Innovex Medical Co., Ltd. is headquartered in China. The company’s location is relevant for understanding its regulatory and manufacturing context, particularly for devices intended for global markets.

Question 3

Which regulatory registries list Innovex Medical Co., Ltd.’s devices?

Accepted Answer

Innovex Medical Co., Ltd.’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry is used to track devices that have undergone regulatory evaluation and compliance checks under EU regulations.

Question 4

How are Innovex Medical Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Innovex Medical Co., Ltd.’s devices fall into Class I and Class IIa categories under EU medical device regulations. Class I devices are generally considered low-risk, while Class IIa devices pose a moderate risk and require additional conformity assessments, such as clinical evaluations or designated conformity assessment procedures.

Device	Model / Reference	Registries	Class	Status
Irrigation Tubing Sets	IVX-IT-M2SY	EUDAMED	Class I	Active
Irrigation Tubing Sets	IVX-IT-M2S	EUDAMED	Class I	Active
Irrigation Tubing Sets	IVX-IT-M1S	EUDAMED	Class I	Active
Irrigation Tubing Sets	IVX-IT-J1S	EUDAMED	Class I	Active
Ureteral Stents	IVX-UT-7022SU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7024CU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7018SULR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6022CL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6024S0	EUDAMED	Class IIa	Active
Irrigation Tubing Sets	IVX-IT-C1S	EUDAMED	Class I	Active
Ureteral Stents	IVX-UT-80MLS0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8022SU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8030CL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7030CL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4824SL	EUDAMED	Class IIa	Active
Ureteral Access Sheaths	IVX-NS-1135	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4820SU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4822CL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7026SULR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7022C0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7020SL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4826CL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-70MLSL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8022SL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6020CU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8024S0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8020C0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4820S0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8024CU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6026CL	EUDAMED	Class IIa	Active
Urological Stone Extraction Baskets	IVX-US-S1410G	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8030S0	EUDAMED	Class IIa	Active
Urological Stone Extraction Baskets	IVX-US-H1410G	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6026C0	EUDAMED	Class IIa	Active
Ureteral Catheters	IVX-UC-0670-SCY	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7020S0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6030SU	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6015SULR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8022S0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7022S0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6030C0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4810S0MR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8028SL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4826SL	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-6028S0	EUDAMED	Class IIa	Active
Ureteral Catheters	IVX-UC-0770-SCY	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-8022C0	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-7026S0LR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4820S0SR	EUDAMED	Class IIa	Active
Ureteral Stents	IVX-UT-4826C0	EUDAMED	Class IIa	Active

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