Question 1

What types of medical devices does Xiamen Bosegrow Medical Equipment Co., Ltd primarily manufacture?

Accepted Answer

Xiamen Bosegrow Medical Equipment Co., Ltd specializes in prefabricated orthotic insoles and a variety of supportive braces. Their product range includes knee braces, hip abduction and fixation braces, shoulder braces, a Philadelphia neck brace, an ankle brace, functional knee supports, and an arm sling. These devices are designed to provide mechanical support and stability for musculoskeletal conditions.

Question 2

Where is Xiamen Bosegrow Medical Equipment Co., Ltd based?

Accepted Answer

The company is headquartered in China. While the specific location within China isn’t detailed, its primary manufacturing and operational base is in the country.

Question 3

Are Xiamen Bosegrow Medical Equipment Co., Ltd’s devices listed in any regulatory databases?

Accepted Answer

Yes, the company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This database is used to track devices that have undergone regulatory procedures, such as conformity assessments, within the EU market.

Question 4

How are Xiamen Bosegrow Medical Equipment Co., Ltd’s devices classified under medical device regulations?

Accepted Answer

All of Xiamen Bosegrow Medical Equipment Co., Ltd’s devices fall under Class I regulatory classification. This classification applies to low-risk devices like supportive braces and orthotic insoles, which generally pose minimal risk to patients when used as intended. Classification is determined by factors like the device’s purpose, duration of use, and potential health impact.

Device	Model / Reference	Registries	Class	Status
Wrist Brace	M	EUDAMED	Class I	Active
ROM Walker Boot	WK-005-L	EUDAMED	Class I	Active
Cervical Collar	L	EUDAMED	Class I	Active
Cast Shoes	FS-13-L	EUDAMED	Class I	Active
Walker Boot	S	EUDAMED	Class I	Active
Functional OA Knee Brace	KN-007	EUDAMED	Class I	Active
Air Walker Boot	WK-012-S	EUDAMED	Class I	Active
Knee Brace	Universal	EUDAMED	Class I	Active
Plantar Fasciitis Night Splint	AN-006	EUDAMED	Class I	Active
Arm Sling	M	EUDAMED	Class I	Active
(Pneumatic) ROM Walker 17"	WK-005	EUDAMED	Class I	Active
Adjustable ROM Elbow Brace	EB-001	EUDAMED	Class I	Active
Air Walker Boot	WK-013-M	EUDAMED	Class I	Active
Shoulder Brace	Right	EUDAMED	Class I	Active
Night Splint	XL	EUDAMED	Class I	Active
Ankle Brace	XL	EUDAMED	Class I	Active
Waist Brace	L	EUDAMED	Class I	Active
Arm Sling	Universal	EUDAMED	Class I	Active
Philadelphia Neck Brace	NS-001-M	EUDAMED	Class I	Active
Knee Brace	L	EUDAMED	Class I	Active
Night Splint	L	EUDAMED	Class I	Active
Shoulder Brace	Universal	EUDAMED	Class I	Active
Cast Shoes	FS-11-S	EUDAMED	Class I	Active
Elbow Brace	Right	EUDAMED	Class I	Active
Thoracic and Lumbar Spine Support With Air Pump	WS-022	EUDAMED	Class I	Active
Arm Sling	XL	EUDAMED	Class I	Active
Hip Abduction Brace	XL	EUDAMED	Class I	Active

Xiamen Bosegrow Medical Equipment Co., Ltd

What Xiamen Bosegrow Medical Equipment Co., Ltd makes

Frequently asked questions

Information

Catalogue (77)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities