FDA Registration
Active
🇧🇲 Bermuda
MEDTECS INTERNATIONAL CORPORATION LIMITED
Reg #: 3017171460
·
FEI: 3017171460
·
Expires 2026
Products
19
Proprietary Names
38
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- MEDTECS INTERNATIONAL CORPORATION LIMITED
- Registration Number
- 3017171460
- FEI Number
- 3017171460
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Clarendon House, 2 Church Street
- City
- City of Hamilton
- Country
- BM
Regulatory Submissions
- 510(k) Number
- K203376
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 |
|---|---|---|---|---|---|
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2020-05-26 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2020-05-26 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-05-26 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-03-06 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2023-08-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-07-31 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-01-12 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-01-12 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-01-12 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-01-12 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | 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, Examination | FME | Class 1 | General Hospital | No | 2020-05-26 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-05-26 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-05-26 |
Proprietary Names
Mattress Pad
Mattress Cover (Medical purpose)-STRETCHER SHEETS
shoes covers
Operating-Room Shoe Cover
UNDERCAST PADDING
Flat/Fitted Sheets
Operating Room Towel
Pillowcases
Disposable Medical Mask
Disposable Medical Mask (Non-sterile)
Face Shield
Medical Goggles
Gloves (Disposable Rubber Gloves)
Medical Face Shield
Protective Mask
Cuff Barrier Sleeve
Surgical Masks
Isolation Gown
Disposable Isolation Gown
Coverall with tape
Disposable Coverall
Chemo Gown
AMD-Ritmed AssureWear Versagown
Conductive Shoe and Shoe Cover
Surgical Gowns
Glove
Examination Glove
Nitrile Powder Free Examination Glove
Wheelchair Cushion
ASTM PB70 Level 4 Isolation Gown
ISO Gown
PATIENT EXAM GOWN
Infant Shirt
Surgical Cap
Bouffant Cap
Elastic Bandage
Elastic
Bandage
Establishment Types
Export Device to the United States But Perform No Other Operation on Device