FDA Registration
Active
🇨🇳 China
JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3014739961
·
FEI: 3014739961
·
Expires 2026
Products
31
Proprietary Names
44
Establishment Types
2
Classifications
31
Registration Details
- Registration Name
- JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3014739961
- FEI Number
- 3014739961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 19, Renmin East Road, Yangshe Town,
- City
- Zhangjiagang City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Jiangsu Rooe Medical Technology Co., Ltd.
- Operator Number
- 10091569
- Address
- No. 19, Renmin East Road, Yangshe Town,
- City
- Zhangjiagang City
- State
- Jiangsu
- Postal Code
- 215600
- Country
- CN
- Correspondent
- DORIS LIU
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2024-10-16 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2024-10-16 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2024-10-16 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2024-10-16 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2024-10-16 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2024-10-16 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2024-10-16 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-10-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2026-01-04 |
| Cpr Aid Device Without Feedback | PMK | Class 1 | Cardiovascular | No | 2024-10-16 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2024-10-16 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2024-10-16 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2024-10-16 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2024-10-16 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2024-10-16 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2024-10-16 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2024-10-16 |
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2024-10-16 |
| Washer Of Body Waste Receptacles | FLH | Class 1 | General Hospital | No | 2024-10-16 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2024-10-16 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2026-01-04 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2024-10-16 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2026-01-04 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2024-10-16 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2024-10-16 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2024-10-16 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2024-10-16 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2024-10-16 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2024-10-16 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2024-10-16 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2024-10-16 |
Proprietary Names
ROOE Medical Electric Hydraulic Operation Table Electric Operation Table, Manual Hydraulic Operation Table,
Manual Operation Table, Obstetric Table
Blood Bank
PH Meter: Biological Safety Cabinet, Laminar Flow Cabinet Ultrasonic Cleaner, Pipette, Microtome, Laboratory Freezer,
Analysis Balance, Medical Centrifuge, Shaker, Mixer, Thermostatic Bath, Stirrer, Water Distiller, Laboratory incubator,
ROOE Medical Dental Unit, Dental Accessories
Anesthesia trolley, ABS cart, dressing trolley; Emergency Trolley, Medical Workstation trolley, Medicine trolley,
Patient trolley, transfer trolley
Continuous Passive Motion FInger CPM-Finfer; CPM
ROOE Medical Electrocardiograph MachineECG Machine, EkG Machine
Medical Bed Mattress, Bed Sheet, Bed Cover, Warming Blanket, Air Mattress, Water Mattress,
Bedsore Prevention Mattress
Disposable Manual Resuscitator; Manual emergency ventilator(Resuscitator); PVC Manual Resuscitator
Corpse Transportation Trolley
Mortuary Refrigerator, Trash Can; Mortuary Equipment: Corpse; Storage Shelf, Autopsy Table, Body bag,
ROOE Medical CPR Aid Device, CPR Training Defibrillator CPR Training AED, CPR Training Manikin, Nurse Training Manikin
Cabinet, Table and Tray, Anesthesia
ROOE Medical Sterilizer, Autoclave, Steam Sterilizer, Uv Sterilizer, Dry Heat Sterilizer
Ophthalmic Table
ROOE Medical Dental Chair, Bedside Table; Medical Chair, Dialysis Chair, ENT Chair, Waiting Chair, Infusion Chair,
Ophthalmic Chair, Blood Donor Chair, Accompany Chair, Bath Chair, Over-Bed Table, ENT Table, Folding Table,
Extremity Kit; Extrication Device; Head Immobilizer; Straps; Traction Leg Splint
Stretcher, Hand-Carried
ROOE Medical X-Ray System, Radiography XRay System, DR X-Ray System, C-Arm X-Ray System, Mammography X-Ray System
Medical Stretcher Wheeled; Stretcher
Blood Bank Refrigerator; Car Refrigerator; Combination Freezer; Corpse Refrigerator;Double Door Laboratory Refrigerator;
Ultra Low Temperature Freezer; Upright Freezer
Mini Laboratory Refrigerator; Portable Refrigerator; Single Door Laboratory Refrigerator; Solar Refrigerator;
Washer Of Body Waste Receptacles
PATIENT LIFT
Mortuary table Electric, Autopsy Table, Examination Table
ROOE Medical Monitor, Bed Patient Monitor, Blood Pressure Monitor Fetal Monitor, Baby Monitor
TOURNIQUET, PNEUMATIC
Patient transfer device, transfer trolley
Examination Bed; Children Bed, Beauty Bed, Massage Bed, Hospital Bed Accessory
ROOE Medical Manual Hospital Bed, General Hospital Bed, ICU Bed, Obstetric Bed, Delivery Bed, Examination Bed;
ROOE Electric Suction Unit; Manual Suction Unit; Sputum Suction Unit
Electric Examination Bed, Electric lCU Bed, Electric Children Bed, Electric Beauty Bed, Electric Massage Bed,
Bed, Ac-Powered Adjustable Hospital, ROOE Medical Electric Hospital Bed, Electric Obstetric Bed, Electric Delivery Bed,
Hospital Bed Accessory
ROOE Medical LED Operation Lamp, LED Surgical Lamp, LED Examination Light
ROOE Medical Washing Sink, Wash Stand, Medical Hand Sink, Washing Tank, Washing Tub
Medical Pendant, TABLE, OPERATING-ROOM. AC
ROOE Medical Halogen Operation Lamp, Surgical Operation Light, Examination Light
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device