Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006266055

FEI Number

3006266055

Entity Name

XIAMEN CHENGLI MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

8F,Building 1, No3 Kenping Road Haiyi Industrial Park, Jimei District Xiamen, Xiamen Fujian 361022, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XIAMEN CHENGLI MEDICAL EQUIPMENT CO., LTD. (Owner Number: 9100300)

Owner / Operator Contact Address

8F, Building 1,No3 Kenping Road Haiyi Industrial Park, Jimei District, XIAMEN, CN-FJ 361022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Joint Knee external brace Cast shoes, Cast Cover walker AIR A MED PLUS OTHERS Face Mask, Medical AIR A MED PLUS OTHERS eye shields scrotal support Abdominal Support Hernia Guard Maternity Support Hernia Support Vertaloc Thoracic Orthoses Clavicle Splints Cervical-Thoracic Support Sacroliliac Orthoses Clavicle S Abdominal Support Rib Fracture Support Cervical Support Lumbar Support Lumbo-Sacral Support Vertaloc knee brace Leg Brace Arm Brace Support Glove Hand Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-04-03
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2009-08-26
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2007-04-12
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-19
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2007-04-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-06
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2009-08-26
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2009-05-26
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2009-06-30
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2009-06-30

Official Correspondent

Maple Wu

US Agent Details

JOHN Samorajczyk Business: SAMORAJCZYK REGULATORY CONSULTANTS, LLC. Email: JSAMO@PRODIGY.NET Phone: (727) 4803810

Related Public Records

Same Entity

XIAMEN CHENGLI MEDICAL EQUIPMENT CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

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2183520	Tenacious Holdings Inc	Saint Paul, MN, US
3010239526	Simple Manufacturing DG Ltd	Dongguan City Guangdong, CN
3030683078	HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006266055. Last updated year: 2026. Please use registration number 3006266055 when referencing this establishment in official correspondence.