FDA Registration
Active
🇰🇷 South Korea
GD GROUP CO., LTD.
Reg #: 3016788237
·
FEI: 3016788237
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- GD GROUP CO., LTD.
- Registration Number
- 3016788237
- FEI Number
- 3016788237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 29 Seongbonsandan 6-ro,, Geumwang-eup
- City
- Eumseong Chungbuk
- Country
- KR
Owner / Operator
- Firm Name
- GANGDONG GROUP CO., LTD.
- Operator Number
- 10078653
- Address
- 29 Seongbonsandan 6-ro, Geumwang-eup
- City
- Eumseong
- State
- Chungbuk
- Postal Code
- 27741
- Country
- KR
- Correspondent
- SANGHOON KANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2024-02-03 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2020-10-30 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-10-30 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2024-02-07 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2025-09-21 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2024-02-03 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2020-11-02 |
Proprietary Names
Low Profile Microtome Blades 35L; High Profile Microtome Blades 35H; Trimming Blades
Embedding Cassette; Biopsy Cassette; Tissue Cassette; Hinged Cassette
Ethanol 70%; Ethanol 83%; Ethanol 95%; Ethanol 100%; Isopropyl Alcohol, Xylene; Toluene; Acetone
FIXUP®, Fixative Solution
PathoLock; 10% Neutral Buffered Formalin
Adhesion slides, Non-Adhesion slides, Coverslips
OptimalHisto, LumiTreat
5mL Tube; 12mL Tube; 20mL Container; 30mL Container; 60mL Container; 90mL Container; 120mL Container
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device