Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020188747

FEI Number

3020188747

Entity Name

ZJG ROYALTRUST MED CO., LTD.

City/State/Country

Zhangjiagang City Jiangsu, CN

Establishment Address

LeLeyu Town, Zhangjiagang City Jiangsu 215621, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZJG Royaltrust Med Co., Ltd. (Owner Number: 10089144)

Owner / Operator Contact Address

LeLeyu Town, Zhangjiagang City, CN-JS 215621, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trolley (Emergency Trolley, Medicine Trolley) Stethoscope Chest Seal Patient Transparent Stretcher, Stretcher Base, Spine Board Stretcher) Multifunction Roll Stretcher, Vacuum Stretcher, Basket Stretcher, Stair Chair Stretcher, Stretcher (Ambulance Stretcher, Folding Stretcher, Scoop Stretcher, Soft Stretcher, Military Folding Cot Stretcher, Manual Suction Pump Board (CPR Board) CPR Mask CPR training simulator Life vest, Life buoy, Buoy can, Buoy tube, Life wristband, Life float, Life rope PERCUSSOR Head Immobilizer Splint (Roll Splint, Finger Splint, Arm Splint, Leg Splint, Splint Set, Vacuum Splint, Air Splint) Pelvic Sling Band Kit/Bag/Box (First Aid Kit, First Aid Box, First Aid Bag, Home Care) Cervical Collar Bandage Cylinder IV.Stand Bandage Gauze / Sponge, Nonresorbable for External Use - Trauma Dressing, Kaolin Hemostatic Gauze Weighting Scale Tourniquet Truncal/Orthosis (Extrication Device, Traction Set) Regulator Crutch Bed (Rescue Bed, Patient Bed, Folding Bed, Examining Bed, Massage Bed)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2023-11-09
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-11-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-11-09
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2023-11-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2026-01-06
FOA	Board, Cardiopulmonary	General Hospital	Class 1	880.6080	2023-11-09
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-11-09
PMK	Cpr Aid Device Without Feedback	Cardiovascular	Class 1	870.5210	2024-12-30
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2025-05-13
GWZ	Percussor	Neurology	Class 1	882.1700	2026-05-05
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2023-11-09
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-11-09
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2024-12-30
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2023-11-09
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2023-11-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-11-09
ECX	Cylinder, Compressed Gas, And Valve	Anesthesiology	Class 1	868.2700	2023-11-09
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2023-11-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-11-09
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-04-15
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2024-12-30
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-11-09
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2023-11-09
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2023-11-09
IPR	Crutch	Physical Medicine	Class 1	890.3150	2023-11-09
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2023-11-09

Official Correspondent

Jingyu He

US Agent Details

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

Related Public Records

Same Entity

ZJG Royaltrust Med 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3030192580	XIAMEN LIYUAN METAL. CO.,LTD.	Xiamen Fujian, CN
3014383485	HUBEI YINKANG MEDICAL EQUIPMENT CO., LTD	Xiaogan Hubei, CN
3013404959	Viant San Antonio, Inc.	San Antonio, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020188747. Last updated year: 2026. Please use registration number 3020188747 when referencing this establishment in official correspondence.