Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012911717

FEI Number

3012911717

Entity Name

CHONG-Z(XIAMEN) INDUSTRIAL & TRADING LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

2nd Floor, No.96, Jing Quan Road,, Jimei District, Xiamen Fujian 361024, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

CHONG-Z(XIAMEN) INDUSTRIAL & TRADING LTD. (Owner Number: 10050662)

Owner / Operator Contact Address

2nd Floor, No.96, Jing Quan Road,, Jimei District, Xiamen, CN-NOTA 361024, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMFORT ZONE MATTRESS AND PUMP COMFORT ZONE BARIATRIC 48" - ALTERNATING PRESSURE LOW AIR LOSS MATTRESS COMFORT ZONE BARIATRIC 42" - ALTERNATING PRESSURE LOW AIR LOSS MATTRESS COMFORT ZONE 36" ALTERNATING PRESSURE LOW AIR LOSS MATTRESS COMFORT ZONE 36" - ALTERNATING PRESSURE LOW AIR LOSS MATTRESS with BUILT-IN PERIMETER AL20 ALTER LIGHT AL24 ALTER LIGHT AL22 ALTER LIGHT AL18 ALTER LIGHT Bubble pad BP300

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2015-12-14

Official Correspondent

Lena Lau

US Agent Details

David Zytman Business: MEDACURE INC. Email: matt.dryden@promedic.cc Phone: (347) 7214346

Related Public Records

Same Entity

CHONG-Z(XIAMEN) INDUSTRIAL & TRADING LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012911717. Last updated year: 2026. Please use registration number 3012911717 when referencing this establishment in official correspondence.