FDA Registration
Active
🇰🇷 South Korea
SYNOTEX MASK (White)
Reg #: 3017676140
·
FEI: 3017676140
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SYNOPEX BIOFILTER
- Registration Number
- 3017676140
- FEI Number
- 3017676140
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 54-42, Dongtanhana 1-gil
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- SYNOPEX BIOFILTER
- Operator Number
- 10078178
- Address
- 54-42, Dongtanhana 1-gil
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18423
- Country
- KR
- Correspondent
- Ha-Na Lee
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| 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 | 2020-10-13 |
Proprietary Names
SYNOTEX MASK (White)
SYNOTEX MASK (Pink)
SYNOPEX ABSOLUTE MB MASK (Light Gray)
SYNOTEX MASK (Light Pink)
SYNOTEX MASK (Beige)
SYNOTEX MASK (Dark Gray)
SYNOTEX MASK (Black)
SYNOPEX ABSOLUTE MB MASK (Khaki)
SYNOTEX MASK (Light Gray)
SYNOPEX ABSOLUTE MB MASK (Dark Gray)
SYNOPEX ABSOLUTE MB MASK (White)
SYNOPEX ABSOLUTE MB MASK (Pink)
SYNOPEX ABSOLUTE MB MASK (Light Pink)
SYNOPEX ABSOLUTE MB MASK (Beige)
SYNOPEX ABSOLUTE MB MASK (Black)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)