FDA Registration
Active
🇹🇼 Taiwan
FUNG LEAD MEDICAL & SPORTS CO., LTD.
Reg #: 3009009512
·
FEI: 3009009512
·
Expires 2026
Products
19
Proprietary Names
19
Establishment Types
2
Classifications
19
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Registration Details
- Registration Name
- FUNG LEAD MEDICAL & SPORTS CO., LTD.
- Registration Number
- 3009009512
- FEI Number
- 3009009512
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F, No.13, Yongxing Road
- City
- Nantou City
- Country
- TW
Owner / Operator
- Firm Name
- Fung Lead Medical & Sports Co., Ltd.
- Operator Number
- 10044100
- Address
- 3F, No.13, Yongxing Road
- City
- Nantou City
- State
- TW-NAN
- Postal Code
- 54067
- Country
- TW
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2013-04-30 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2013-04-30 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-06-04 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2016-02-25 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2024-06-16 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2019-03-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-29 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2016-02-25 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2013-04-30 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2015-08-07 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2013-04-30 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-29 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-29 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-06-16 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2013-04-30 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2017-08-02 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2013-04-30 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2013-04-30 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2013-04-30 |
Proprietary Names
Arm Support
Corrective Shoe Orthosis
Protective Suit
Shoe Cast
Medical Support Stocking (For General Medical Purposes)
Limb Orthosis Brace
Surgical Apparel
Lumbar Orthosis
Arm Sling
Arthroscopy Holder
Limb Orthosis
Face Mask
Isolation Gown
Elastic Bandage
Cervical Orthosis
Filter Blue Glasses
Knee Cage
Ankle External Brace
Knee External Brace
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device