FDA Registration
Active
🇰🇭 Cambodia
COPIOUS (CAMBODIA) INTERNATIONAL INC.
Reg #: 3011545608
·
FEI: 3011545608
·
Expires 2026
Products
15
Proprietary Names
9
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- COPIOUS (CAMBODIA) INTERNATIONAL INC.
- Registration Number
- 3011545608
- FEI Number
- 3011545608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- National Road Number 2, Km No 68, Phum Roung, Khum Lum Chang, Srok Samrong
- City
- Takeo
- Country
- KH
Owner / Operator
- Firm Name
- Copious (Cambodia) International Inc.
- Operator Number
- 10048867
- Address
- National Road Number 2, Km No 68, Phum Roung, Khum Lum Chang, Srok Samraon
- City
- Takeo
- State
- KH-NOTA
- Postal Code
- 21356
- Country
- KH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2017-12-04 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2024-09-08 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-06-16 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-10 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2022-06-16 |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | Class 2 | General, Plastic Surgery | No | 2025-07-14 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2025-07-14 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2015-03-12 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2022-06-16 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-02-19 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-09-05 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2022-06-16 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2019-05-01 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2017-10-31 |
Proprietary Names
Opt-Shield Air Supine
NA
Copioumed Chemotherapy Isolation Gown
Isolation gown
TBD
Facemask
BEDDING, DISPOSABLE, MEDICAL
Opt-Shield Air Lithotomy
Protective Gown
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device