FDA Registration
Active
🇨🇳 China
Shanghai Leison Medical & Healthcare Products Co., Ltd
Reg #: 3007774549
·
FEI: 3007774549
·
Expires 2026
Products
32
Proprietary Names
11
Establishment Types
3
Classifications
32
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Registration Details
- Registration Name
- Shanghai Leison Medical & Healthcare Products Co., Ltd
- Registration Number
- 3007774549
- FEI Number
- 3007774549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.99, West Puhong Road, Zhuqiao Town, Pudong New Area
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Leison Medical & Healthcare Products Co., Ltd
- Operator Number
- 10030026
- Address
- No.99, West Puhong Road, Zhuqiao Town, Pudong New Area
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201324
- Country
- CN
- Correspondent
- Stony Zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2009-08-01 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2009-08-01 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2009-08-01 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2015-12-16 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2014-12-16 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2009-08-01 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2014-12-16 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2017-11-09 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2009-08-01 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2017-11-09 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2009-08-01 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2009-08-01 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2009-08-01 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2015-12-16 |
| Splint, Temporary Training | IQM | Class 1 | Physical Medicine | No | 2015-12-16 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2014-12-16 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2009-08-01 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2009-08-01 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2009-08-01 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2009-08-01 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2009-08-01 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 2009-08-01 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2009-08-01 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2009-08-01 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2009-08-01 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2009-08-01 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2009-08-01 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2014-12-16 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2009-08-01 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2012-12-28 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2015-12-16 |
Proprietary Names
BACK/LEG/HEEL/FOORT/TOE CUSHION, SILICON CUSHION
Cold Treatmeat System, Cold Therapy
Pelvic Support
Limb Holder Quick Release, Body Holder
Splint, Extremity, Inflatable, External
Bunion Splint; Dorsal Night Splint; Night Splint; Plantar Fascitic Soft Night Splint
Ice Bag
NEOBRACE
EXTERNAL BRACE
TAPES, MEASURING, RULERS AND CALIPERS
Hernia Aid
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