FDA Registration Active 🇰🇷 South Korea

PATHPLORER Cervical Oral Solution

Reg #: 3011496777 · FEI: 3011496777 · Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1

Registration Details

Registration Name
BIODYNE
Registration Number
3011496777
FEI Number
3011496777
Status
Active
Expiry Year
2025
Initial Importer
No
Address
24-4 Achasan-ro, 5-gil, Seongdong-gu
City
Seoul
Country
KR

Owner / Operator

Firm Name
Biodyne
Operator Number
10047880
Address
24-4 Achasan-ro, 5-gil, Seongdong-gu
City
Seoul
State
KR-11
Postal Code
04793
Country
KR
Correspondent
Wookbin Im

US Agent

Business Name
HSchem America
Contact Name
Won Woo Suh
Address
1717 Chantilly Ln
City
Fullerton
State
CA
ZIP
92833
Country
US
Phone
213 5597719

Products

Device Name Product Code
Preservative, Cytological LEA

Proprietary Names

PATHPLORER Cervical Oral Solution PATHPLORER Respiratory Tract Solution PATHPLORER Urine-CSF Solution PATHPLORER Gyn Lysis Solution PATHPLORER Dilute Solution PATHPLORER Urine Bottle PATHPLORER Body Fluid-FNA Solution PATHPLORER Non-Gyn Lysis Solution

Establishment Types

Manufacture Medical Device