FDA Registration
Active
🇹🇼 Taiwan
LU MARK ENTERPRISES, INC.
Reg #: 9611559
·
FEI: 3003255513
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- LU MARK ENTERPRISES, INC.
- Registration Number
- 9611559
- FEI Number
- 3003255513
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.257, SEC. 2, ZHONGSHAN E. RD
- City
- XINWU Dist. Taoyuan
- Country
- TW
Owner / Operator
- Firm Name
- LU MARK ENTERPRISES, INC.
- Operator Number
- 9044328
- Address
- XINWU DISTRICT, SEC. 2, ZHONGSHAN E. RD. NO. 257
- City
- TAOYUAN
- State
- TW-TAO
- Postal Code
- 32741
- Country
- TW
- Correspondent
- MARK - LU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2020-08-12 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2001-01-12 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2018-11-05 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2018-11-05 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2014-02-06 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2011-03-29 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2011-03-29 |
Proprietary Names
Arctic System
Aqua relief System
Gel Therapy Wraps
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device