FDA Registration
Active
🇰🇷 South Korea
PNUADD Taper Surgical KIT_Fixture Driver, Depth Gauge, Torque Ratchet
Reg #: 3012564447
·
FEI: 3012564447
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HUMEDITECH CO., LTD
- Registration Number
- 3012564447
- FEI Number
- 3012564447
- Status
- Active
- Expiry Year
- 2025
- 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
PNUADD Taper Surgical KIT_Fixture Driver, Depth Gauge, Torque Ratchet
UG KIT_Drill Guide, Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench
PNUADD Taper Surgical KIT_Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill
NRG KIT_Guide Tissue Punch, Drill Guide, Guide Fixture Driver, Drill Extension
SG KIT_Fixture Driver, Hand Driver, Mount Driver, Lateral Anchor Drill, Lateral Anchor Driver
NRG KIT_Guide Taper Drill, Guide Point Drill, Guide Initial Drill
SG KIT_Lateral Anchor Screw, Vertical Anchor Screw, Torque Wrench, Drill Guide, Guide Counter Sink
TG KIT_Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench
PNUADD Taper Surgical KIT_Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver
UG KIT_Guide Point Drill, Guide Initial Drill, Guide Straight Drill, Guide Tissue Punch, Bone Profiler
SG KIT_Guide Initial Drill, Guide Taper Drill, Guide Point Drill, Guide Tissue Punch
TG KIT_Guide Fixture Driver, Bone Profiler, Vertical Anchor Screw, Drill Guide, Mount Driver, Hand Driver
TG KIT_Guide Point Drill, Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch
Establishment Types
Manufacture Medical Device