Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017637606

FEI Number

3017637606

Entity Name

ZHENG HE CROSS-BORDER LIMITED

City/State/Country

Hong Kong, CN

Establishment Address

ROOM Q, UNIT 608, 6/F., METRO LOFT, 38 KWAI HEI STREET, KWAI CHUNG, N.T., Hong Kong 999077, CN

Establishment Type(s)

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

Owner / Operator

ZHENG HE CROSS-BORDER LIMITED (Owner Number: 10090871)

Owner / Operator Contact Address

ROOM Q, UNIT 608, 6/F., METRO LOFT, 38 KWAI HEI STREET, KWAI CHUNG, N.T., HONG KONG, CN-NOTA 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Examing Table, Massage Table Electric Nursing Bed Electric Hospital Bed Medical Chairs, Medical Recliner Medical Pharmacy, Refrigerator Medical, Refrigerator, Lab Refrigerator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2024-05-26
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-05-26
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-05-26
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2024-05-26
JRM	Freezer	Clinical Chemistry	Class 1	862.2050	2026-03-04

Official Correspondent

Liu Dong

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

ZHENG HE CROSS-BORDER LIMITED

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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

Similar Registrations

Registration Number	Establishment Name	Location
3008643402	MT TABLES, LLC	Aurora, MO, US
2183634	ALTIMATE MEDICAL, INC.	MORTON, MN, US
3007029061	PARAMOUNT BED CO., LTD. Chiba Factory	Sammu-shi Chiba, JP
3007309323	ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD	ZHENJIANG CITY Jiangsu, CN
3008261413	DJO CANADA INC.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017637606. Last updated year: 2026. Please use registration number 3017637606 when referencing this establishment in official correspondence.