FDA Registration
Active
🇨🇳 China
XIAMEN LONGSTAR MEDICAL EQUIPMENT CO.,LTD
Reg #: 3017610906
·
FEI: 3017610906
·
Expires 2026
Products
13
Proprietary Names
35
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- XIAMEN LONGSTAR MEDICAL EQUIPMENT CO.,LTD
- Registration Number
- 3017610906
- FEI Number
- 3017610906
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5F, 87#, Huli Park, Tong an Industrial Concentration Area
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen LongStar Medical Equipment Co.,Ltd
- Operator Number
- 10078112
- Address
- 5F, 87#, Huli Park, Tong'an Industrial Concentration Area
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361100
- Country
- CN
- Correspondent
- Anna Wu
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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-10-10 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2020-10-10 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2025-05-20 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2024-11-28 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2024-11-28 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2020-10-10 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2020-10-10 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2022-12-09 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2024-11-28 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 2020-10-10 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-08-14 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2020-10-10 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2025-05-20 |
Proprietary Names
Orthosis LIMB
POST OP SHOE
joint, ankle brace
A12 ANKLE AIR WALKER BRACE - XL
A12 ANKLE AIR WALKER BRACE - SMALL
A12 ANKLE AIR WALKER BRACE - MEDIUM
A12 ANKLE AIR WALKER BRACE - LARGE
Walking Aid
Hernia Belt
Finger gloves
Elbow & Hand splint
Orthosis back and arm splint
ORTHOSIS LUMBAR
Hip Brace
Orthosis Cervical
CERVICAL COLLAR
Orthosis Knee brace
Z1 K11 Knee Support Brace Small
Z1 K7 Knee Brace XL Right
Z1 K7 Knee Brace Small Left
Z1 K11 Knee Support Brace Large
Z1 K7 Knee Brace Medium Right
Z1 K8 Knee Brace Left
Z1 K7 Knee Brace Large Left
Z1 K7 Knee Brace Large Right
Z1 K11 Knee Support Brace Medium
Z1 K11 Knee Support Brace XL
Z1 K9 ROM Knee Brace
Z1 K7 Knee Brace Medium Left
Z1 K10 ROM Knee Brace
Z1 K8 Knee Brace Right
Z1 K7 Knee Brace XL Left
Z1 K7 Knee Brace Small Right
Post-op Shoes
Crutch
Establishment Types
Manufacture Medical Device