Question 1

What types of medical devices does Dongguan Jiuhui Industrial Limited manufacture?

Accepted Answer

Dongguan Jiuhui Industrial Limited specializes in prefabricated orthotic insoles and toe straightener separators. These devices are designed to offer foot support and help correct toe alignment, particularly for conditions where proper alignment is beneficial. The company focuses on non-antimicrobial versions of these products.

Question 2

Where is Dongguan Jiuhui Industrial Limited based?

Accepted Answer

The company is based in China, specifically in Dongguan. This location serves as its primary manufacturing and operational hub for its orthotic and toe alignment devices.

Question 3

Which regulatory registries list the devices manufactured by Dongguan Jiuhui Industrial Limited?

Accepted Answer

The devices produced by Dongguan Jiuhui Industrial Limited are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary regulatory processes to be placed on the EU market.

Question 4

How are the devices from Dongguan Jiuhui Industrial Limited classified under EU regulations?

Accepted Answer

The company’s devices, including prefabricated orthotic insoles and toe straightener separators, fall under Class I classification in the EU regulatory framework. This classification applies to low-risk medical devices that pose minimal risk to patients and users, such as certain orthotic and support products.

Device	Model / Reference	Registries	Class	Status
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Bunion Corrector	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Jpg-54	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Jpg-23	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Jhw9-007	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Toe Straightener toe Seperator	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active
Insole	N/A	EUDAMED	Class I	Active

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