FDA Registration
Active
🇹🇼 Taiwan
Medicom Asia-Pacific Holdings Limited. Taiwan Branch
Reg #: 3008132392
·
FEI: 3008132392
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- Medicom Asia-Pacific Holdings Limited. Taiwan Branch
- Registration Number
- 3008132392
- FEI Number
- 3008132392
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.11, Sec2, Ligong 1st Rd
- City
- Wujie Township Yilan
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K243431
Owner / Operator
- Firm Name
- Medicom Group
- Operator Number
- 9007111
- Address
- 2555 Chemin De L Aviation
- City
- Pointe Claire
- State
- Quebec
- Postal Code
- H9P 2Z2
- Country
- CA
US Agent
- Business Name
- United Medical Enterprise
- Contact Name
- Brent Geiger
- Address
- 3301 Stagecoach, Rd NE Thomson
- City
- Thomson
- State
- GA
- ZIP
- 30824
- Country
- US
- [email protected]
- Phone
- 763 2189292
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2001-01-30 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2025-04-09 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-04-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 1996-05-01 |
Proprietary Names
Medicom Sterilization Pouches & Reels
Pouches & Reels
Medicom SafeBasics
Medicom SafeMask
Medicom AssureMask
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device