Question 1

What types of medical devices does A & I Industries Ltd Shunde Foshan manufacture?

Accepted Answer

A & I Industries Ltd Shunde Foshan specializes in mobility assistance products. Their portfolio includes four-wheel vehicles and multiple variants of manual wheelchairs, all designed to support transportation and independent movement for users.

Question 2

Where is A & I Industries Ltd Shunde Foshan based?

Accepted Answer

The company is headquartered in China, specifically in Shunde, Foshan. This location serves as its primary manufacturing and operational base for its mobility-related medical devices.

Question 3

Which regulatory registries list devices manufactured by A & I Industries Ltd Shunde Foshan?

Accepted Answer

The company’s devices are listed in the EU’s eudamed database, which serves as a central registry for medical devices authorized within the European Union. This inclusion ensures transparency and traceability of their Class I products.

Question 4

How are the devices produced by A & I Industries Ltd Shunde Foshan classified?

Accepted Answer

All devices manufactured by A & I Industries Ltd Shunde Foshan fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as mobility aids like wheelchairs and transport vehicles, where the risk to users is minimal and regulatory oversight is less stringent than for higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Four-Wheel Vehicle	GoMe TWO rollator Rose maat S	EUDAMED	Class I	Active
Four-Wheel Vehicle	GoMe Two rollator Blue maat S	EUDAMED	Class I	Active
Manual wheelchair	318 – 23 46	EUDAMED	Class I	Active
Manual wheelchair	3002 40	EUDAMED	Class I	Active
Manual wheelchair	Primeo 39	EUDAMED	Class I	Active
Manual wheelchair	118 - 23 Plus 43	EUDAMED	Class I	Active
Manual wheelchair	Primeo Plus 42	EUDAMED	Class I	Active
Manual wheelchair	218 – 23 WHD 56	EUDAMED	Class I	Active
Manual wheelchair	318 – 23 51	EUDAMED	Class I	Active
Manual wheelchair	118 - 23 Plus 40	EUDAMED	Class I	Active
Manual wheelchair	UN-09508S-450	EUDAMED	Class I	Active
Manual wheelchair	108 – 23 43	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 Hemi 51	EUDAMED	Class I	Active
Manual wheelchair	118 - 23 43	EUDAMED	Class I	Active
Manual wheelchair	218 – 24 48	EUDAMED	Class I	Active
Manual wheelchair	218 – 24 46	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 Hemi 48	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 Hemi 43	EUDAMED	Class I	Active
Manual wheelchair	Primeo 48	EUDAMED	Class I	Active
Manual wheelchair	3001 51	EUDAMED	Class I	Active
Manual wheelchair	J30-1701	EUDAMED	Class I	Active
Manual wheelchair	108 – 23 48	EUDAMED	Class I	Active
Manual wheelchair	Primeo Plus 48	EUDAMED	Class I	Active
Manual wheelchair	118 - 23 46	EUDAMED	Class I	Active
Manual wheelchair	Relax Comfort 44	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 43	EUDAMED	Class I	Active
Manual wheelchair	J17-1801	EUDAMED	Class I	Active
Manual wheelchair	118 - 23 Plus 48	EUDAMED	Class I	Active
Four-Wheel Vehicle	102 Carbon	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 51	EUDAMED	Class I	Active
Manual wheelchair	Primeo 45	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 Plus 43	EUDAMED	Class I	Active
Four-Wheel Vehicle	GoMe Two rollator Rose maat M	EUDAMED	Class I	Active
Manual wheelchair	J80-1601	EUDAMED	Class I	Active
Manual wheelchair	538 - 23 Plus 51	EUDAMED	Class I	Active
Manual wheelchair	358 - 23 46	EUDAMED	Class I	Active
Manual wheelchair	3001 48	EUDAMED	Class I	Active
Manual wheelchair	J09-1801	EUDAMED	Class I	Active
Manual wheelchair	218 - 23 46	EUDAMED	Class I	Active
Manual wheelchair	318 – 23 48	EUDAMED	Class I	Active
Manual wheelchair	J40-1801	EUDAMED	Class I	Active
Manual wheelchair	J50-1401	EUDAMED	Class I	Active
Manual wheelchair	EB-FCM18-BK-BC	EUDAMED	Class I	Active
Manual wheelchair	J01-1801	EUDAMED	Class I	Active
Manual wheelchair	3001 46	EUDAMED	Class I	Active

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