FDA Registration
Active
🇨🇳 China
JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD
Reg #: 3010373263
·
FEI: 3010373263
·
Expires 2026
Products
34
Proprietary Names
43
Establishment Types
3
Classifications
34
Registration Details
- Registration Name
- JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD
- Registration Number
- 3010373263
- FEI Number
- 3010373263
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.35 Lehong Road, Modern Agriculture Demonstration Park
- City
- Zhangjiagang Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Jiangsu Saikang Medical Equipment Co., Ltd
- Operator Number
- 10043618
- Address
- NO.35 Lehong Road, Modern Agriculture Demonstration Park
- City
- Zhangjiagang
- State
- Jiangsu
- Postal Code
- 215600
- Country
- CN
- Correspondent
- Zhixiang Cai
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 |
|---|---|---|---|---|---|
| Washer Of Body Waste Receptacles | FLH | Class 1 | General Hospital | No | 2017-11-13 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2017-11-13 |
| Screen, Tangent, Projection, Ac-Powered | HOK | Class 1 | Ophthalmic | No | 2020-11-15 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2013-03-06 |
| Kit, First Aid, Talking | OVR | Class 1 | General, Plastic Surgery | No | 2017-11-13 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2017-11-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2020-11-15 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2013-03-06 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2020-11-15 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2017-11-13 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2017-11-13 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2017-11-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-12-03 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2017-11-13 |
| Curtain, Protective, Radiographic | IWQ | Class 1 | Radiology | No | 2023-11-16 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-03-20 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2017-11-13 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-03-20 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2013-03-06 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2017-11-13 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2013-03-06 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2013-03-06 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2020-04-09 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2017-11-13 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2017-11-13 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2017-11-13 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2017-11-13 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 2017-11-13 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2013-03-06 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2023-12-03 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2020-11-15 |
| Chair, Dialysis, Unpowered, Without Scales | FIA | Class 1 | Gastroenterology, Urology | No | 2020-11-15 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2017-11-13 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2013-03-06 |
Proprietary Names
Washing sink
Manual Resuscitator
screen
First aid kit
Sputum suction unit
Manual suction unit
Electric suction unit
IV stand
examination table
Body splint
Aluminum mouldable splint
Finger splint
Rollator
Electric parturition bed, Electric surgical table, Electric delivery bed, Electric gynecological table, Tilting table
Mortuary Refrigerator
Trash Can; Mortuary Equipment: Corpse Storage Shelf, Autopsy Table, Body bag, Corpse Transportation Trolley,
Whole reflector lamp
LED operation lamp
Reflector shadowless lamp
Curtain, Track, Stainless Steel Screen
Sterilizer
Bed Mattress
Dental unit
Stapler
BED, MANUAL; Nursing bed; Manual examination bed; Examination couch
Stretcher, wheeled
Shower chair; Screen
Air mattress
Treatment trolley
Laundry trolley
Wheel Chair
Head immobilizer
Treatment Equipment: Anesthesia Machine, Ventilator, Oxygen Generator, Infusion Pump, Suction Device, Dental Unit, ECG,
Surgical Equipment; Monitoring Equipment: Monitor, Infant Incubator, Sphygmomanometer, Vacuum Extractor
Medical pendant; TABLE, OPERATING-ROOM, AC-POWERED
dialysis chair
Transportation Trolley
Medicine Trolley
Patient trolley
Emergency Trolley with ABS or other material
Connecting trolley
Medical Workstation trolley
Manual delivery couch
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device