Dragon Medical Co.,Ltd

FDA Device Registration & Listing · Suzhou City Jiangsu, CN · Registration 3013524663

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013524663
FEI Number
3013524663
Entity Name
Dragon Medical Co.,Ltd
City/State/Country
Suzhou City Jiangsu, CN
Establishment Address
No.252, West Second Ring Road, Yangshe Town, Zhangjiagang City, Suzhou City Jiangsu 215600, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Dragon Medical Co.,Ltd (Owner Number: 10054765)
Owner / Operator Contact Address
No.252, West Second Ring Road, Yangshe Town, Zhangjiagang City, Suzhou City, CN-JS 215600, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Electric Toothbrush Electric hospital bed, Electric nursing bed Transport Chair Cervical collars, Kendrick Extrication Device, Head immobilizer, Extrication Device massage gun, Eye Massager traction splint Face Mask tourniquet Electric bath lift, Bath lift Shower Bath Trolley, Commode chair, Shower stool, Shower bed, Barrier free tool, Toilet rail, Nasopharyngeal Airway Chest Seal Decompression Needle drip stand Wound Dressing Climber, Wheelchair Teeth Whitening Electric Stretcher CPR Mask vacuum blackhead remover protective goggles Face Shield Alcohol Prep Pads Wheel chairs medical trolley Walking aid head immobilizer CPR board protective suit Walking stick Manual transfer chair, Manual patient lift surgical lamp Laryngoscope Emergency Bandage Emergency blanket, Emergency Sleeping Bag Antiseptic Cleansing Wipe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JEQ Toothbrush, Powered Dental Class 1 872.6865 2019-11-01
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2023-06-08
INM Chair, With Casters Physical Medicine Class 1 890.3100 2022-08-30
IQF Orthosis, Cervical-Thoracic, Rigid Physical Medicine Class 1 890.3490 2022-05-09
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2019-06-06
HSP Splint, Traction Orthopedic Class 1 888.5890 2019-08-30
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2020-03-02
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2019-05-16
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2022-08-30
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2022-08-30
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2019-08-30
BWJ Locator, Acupuncture Point General Hospital Class 2 880.5580 2022-08-30
FOX Stand, Infusion General Hospital Class 1 880.6990 2019-11-01
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2022-08-29
IMN Climber, Curb, Wheelchair Physical Medicine Class 1 890.3920 2020-01-18
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2019-04-26
INK Stretcher, Wheeled, Powered Physical Medicine Class 2 890.3690 2025-05-30
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2022-08-29
KNM Device, Pressure Applying Physical Medicine Class 1 890.5765 2019-04-27
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-03-26
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2026-03-13
KMN Chair And Table, Medical General Hospital Class 1 880.6140 2018-01-18
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2024-03-07
HSS Halter, Head, Traction Orthopedic Class 1 888.5890 2019-08-30
FOA Board, Cardiopulmonary General Hospital Class 1 880.6080 2021-11-15
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-31
IPR Crutch Physical Medicine Class 1 890.3150 2024-03-07
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2024-03-07
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2019-11-01
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2021-06-29
FQM Bandage, Elastic General Hospital Class 1 880.5075 2022-08-29
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2022-04-13
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2026-03-13

Official Correspondent

REBECCA Ren

US Agent Details

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

Related Public Records

Same Entity

Dragon Medical 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
K935837 Healthcare Designs AIRHYTHM HEALTHCARE BED 1994-06-21
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013524663. Last updated year: 2026. Please use registration number 3013524663 when referencing this establishment in official correspondence.
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