FDA Registration
Active
🇰🇷 South Korea
HUMEDITECH CO., LTD
Reg #: 3012564447
·
FEI: 3012564447
·
Expires 2026
Products
1
Proprietary Names
34
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HUMEDITECH CO., LTD
- Registration Number
- 3012564447
- FEI Number
- 3012564447
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26, Yeocha-ro, Saengnim-myeon
- City
- Gimhae-si Gyeongnam
- Country
- KR
Owner / Operator
- Firm Name
- HUMEDITECH Co., Ltd
- Operator Number
- 10091775
- Address
- 26, Yeocha-ro, Saengnim-myeon
- City
- Gimhae-si
- State
- Gyeongnam
- Postal Code
- 50801
- Country
- KR
US Agent
- Business Name
- Withus Group Inc.
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-10-31 |
Proprietary Names
Drill Extension
Initial Drill
Sun-Bone Packer
Three Cutter Twist Drill
Plastic Cap
Twist Drill
TG KIT_Guide Fixture Driver, Bone Profiler, Vertical Anchor Screw, Drill Guide, Mount Driver, Hand Driver
UG KIT_Guide Point Drill, Guide Initial Drill, Guide Straight Drill, Guide Tissue Punch, Bone Profiler
TG KIT_Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench
UG KIT_Drill Guide, Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench
NRG KIT_Guide Tissue Punch, Drill Guide, Guide Fixture Driver, Drill Extension
PNUADD Taper Surgical KIT_Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver
NRG KIT_Guide Taper Drill, Guide Point Drill, Guide Initial Drill
PNUADD Taper Surgical KIT_Fixture Driver, Depth Gauge, Torque Ratchet
C-Bone Packer
SG KIT_Guide Initial Drill, Guide Taper Drill, Guide Point Drill, Guide Tissue Punch
1.2 Hex. Driver Long and Short
Torque Extension
G-Packer
SG KIT_Lateral Anchor Screw, Vertical Anchor Screw, Torque Wrench, Drill Guide, Guide Counter Sink
NoMount Driver Long and Short
Parallel Pin
Taper Drill
TG KIT_Guide Point Drill, Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch
PNUADD Taper Surgical KIT_Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill
Tissue Punch
Kimplant KIT case
Fixture Driver Long and Short
Lance Drill
Taper Cortical Drill
Torque Wrench
Kimplant KIT
SG KIT_Fixture Driver, Hand Driver, Mount Driver, Lateral Anchor Drill, Lateral Anchor Driver
G-Remover
Establishment Types
Manufacture Medical Device