Question 1

What types of medical devices does Ralon Medical and Science Co., Ltd. primarily manufacture?

Accepted Answer

Ralon Medical and Science Co., Ltd. specializes in non-foldable walking chairs and shower chairs. These devices are designed to assist patients with mobility and hygiene needs in clinical or home care settings. Examples include models like the RL-A42043, RL-S41006, and RL-A42046C, all tailored for stability and ease of use.

Question 2

Where is Ralon Medical and Science Co., Ltd. based?

Accepted Answer

The company is headquartered in China. This geographic location influences its regulatory compliance and manufacturing operations, though individual devices must still meet the requirements of their respective markets for authorization.

Question 3

Which regulatory registries list Ralon Medical and Science Co., Ltd.’s devices?

Accepted Answer

Ralon Medical and Science Co., Ltd.’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for Class I devices, though registration alone does not imply authorization—individual devices must undergo their own assessment processes.

Question 4

How are Ralon Medical and Science Co., Ltd.’s devices classified under medical device regulations?

Accepted Answer

All of Ralon Medical and Science Co., Ltd.’s listed devices fall under Class I classification. This classification is typically assigned to low-risk devices, such as mobility aids like walking chairs and shower chairs, where the risk of harm to the user is minimal. Classification determines the regulatory pathway for authorization, with Class I devices often requiring less stringent scrutiny than higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Rl-A42043	RL-A42043	EUDAMED	Class I	Active
Rl-S41006	RL-S41006	EUDAMED	Class I	Active
Rl-A42046c	RL-A42046C	EUDAMED	Class I	Active
Shower Chair	RL-A60002	EUDAMED	Class I	Active
Rl-A42013	RL-A42013	EUDAMED	Class I	Active
Rl-A42089m	RL-A42089M-GREEN	EUDAMED	Class I	Active
Rl-S42034w	RL-S42034W	EUDAMED	Class I	Active
Rl-A42088	RL-A42088	EUDAMED	Class I	Active
Rl-A42020	RL-A42020	EUDAMED	Class I	Active
Rl-A42045w8	RL-A42045W8	EUDAMED	Class I	Active
Rl-A42048kd	RL-A42048KD	EUDAMED	Class I	Active
Rl-A42117	RL-A42117-Blue	EUDAMED	Class I	Active
Rl-A42089m	RL-A42089M	EUDAMED	Class I	Active
Rl-A42052w12	RL-A42052W12	EUDAMED	Class I	Active

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