FDA Registration
Active
🇰🇭 Cambodia
MEDTECS (CAMBODIA) CORP. LIMITED
Reg #: 3012344767
·
FEI: 3012344767
·
Expires 2026
Products
13
Proprietary Names
24
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- MEDTECS (CAMBODIA) CORP. LIMITED
- Registration Number
- 3012344767
- FEI Number
- 3012344767
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- National road number 7, Phum Ampil Leu, Khum Ampil
- City
- Srok Kampong Siem Kampong Cham
- Country
- KH
Regulatory Submissions
- 510(k) Number
- K210414
Owner / Operator
- Firm Name
- MEDTECS (CAMBODIA) CORP. LIMITED
- Operator Number
- 10074525
- Address
- National road number 7, Phum Ampil Leu, Khum Ampil
- City
- Srok Kampong Siem
- State
- Kampong Cham
- Postal Code
- 030501
- Country
- KH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-05-26 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2020-05-26 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2020-11-13 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-07-31 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | Class 2 | General, Plastic Surgery | No | 2022-11-16 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2022-11-16 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-11-13 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2020-05-26 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-05-26 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
Proprietary Names
ISO Gown
PATIENT EXAM GOWN
Infant Shirt
shoes covers
Operating-Room Shoe Cover
Disposable Isolation Gown
Coverall with tape
Disposable Coverall
Chemo Gown
AMD-Ritmed AssureWear Versagown
UNDERCAST PADDING
Incontinence Pads / Underpad
Surgical Gowns
Surgical Cap
Bouffant Cap
ASTM PB70 Level 4 Isolation Gown
PE Gown
Mattress Pad
Mattress Cover (Medical purpose)-STRETCHER SHEETS
Flat/Fitted Sheets
Operating Room Towel
Pillowcases
Conductive Shoe and Shoe Cover
Isolation Gown
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor