FDA Registration
Active
🇹🇼 Taiwan
SUNDEX CORPORATION
Reg #: 3008076203
·
FEI: 3008076203
·
Expires 2026
Products
14
Proprietary Names
8
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- SUNDEX CORPORATION
- Registration Number
- 3008076203
- FEI Number
- 3008076203
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7F-3, No. 186, SEC. 4, Nanjing E. Rd
- City
- Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K170136
Owner / Operator
- Firm Name
- Sundex Corporation
- Operator Number
- 10041552
- Address
- 5F-9, No. 79, Sec.1, Hsin Tai Wu Road, Hsi-Chih District
- City
- Taipei
- State
- TW-NOTA
- Postal Code
- 22101
- Country
- TW
- Correspondent
- Sophia Chang
US Agent
- Business Name
- Fleet Link, Inc
- Contact Name
- Ingrid Liao
- Address
- 83 Hale St
- City
- Bridgewater
- State
- MA
- ZIP
- 02324
- Country
- US
- [email protected]
- Phone
- 508 2791500 ext. 121
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2023-09-20 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-11-04 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-11-04 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-09-27 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-08-13 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2012-11-05 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2024-11-04 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-11-04 |
| 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 | 2020-04-16 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2012-08-06 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-09-27 |
Proprietary Names
Nitrile Gloves, Scissors
Nitrile Gloves
Cotton applicators
PAD, EYE
Dressing, wound, occlusive
Gauze / sponge,nonresorbable for external use
pick, massaging
BANDAGE, ELASTIC
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device