FDA Registration
Active
🇰🇷 South Korea
CHUNGDO PHARM. CO., LTD.
Reg #: 3007301207
·
FEI: 3007301207
·
Expires 2026
Products
17
Proprietary Names
10
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- CHUNGDO PHARM. CO., LTD.
- Registration Number
- 3007301207
- FEI Number
- 3007301207
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 202 BIO-1, 32 Soyanggang-ro
- City
- Chuncheon-si Gangwon
- Country
- KR
Owner / Operator
- Firm Name
- Chungdo Pharm. Co., Ltd.
- Operator Number
- 10043194
- Address
- 202 BIO-1, 32 Soyanggang-ro
- City
- Chuncheon-si
- State
- Gangwon
- Postal Code
- 24232
- Country
- KR
- Correspondent
- Shon Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2024-03-18 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2013-01-30 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2013-01-30 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| System, Test, Urinary Methylmalonic Acid | LPT | Class 2 | Clinical Chemistry | No | 2025-03-26 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Conversion To Creatinine, Creatine | JLA | Class 1 | Clinical Chemistry | No | 2025-05-25 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Qualitative Chemical Reactions, Urinary Calculi (Stone) | JNQ | Class 1 | Clinical Chemistry | No | 2024-03-18 |
| Acid, Uric, Acid Reduction Of Ferric Ion | LFQ | Class 1 | Clinical Chemistry | No | 2024-03-18 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2013-01-30 |
Proprietary Names
CHEMVIEW-10
Self-Stik Uric Acid
Oxidative Stress Test
Self-Stik FR
Vita-Check
Self-Stik 2MC
AnyScan 300
AnyScan 720
UA 1001
Self-Stik Ca
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device