FDA Registration
Active
🇰🇭 Cambodia
GUARDMED HEALTHCARE KH CO., LTD.
Reg #: 3042251637
·
FEI: 3042251637
·
Expires 2026
Products
29
Proprietary Names
29
Establishment Types
3
Classifications
29
Registration Details
- Registration Name
- GUARDMED HEALTHCARE KH CO., LTD.
- Registration Number
- 3042251637
- FEI Number
- 3042251637
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Aopheasang Village, Kandoeng Commune, Bati District, Takeo Province, Cambodia.
- City
- Bati District Takeo
- Country
- KH
Owner / Operator
- Firm Name
- GUARDMED HEALTHCARE KH CO., LTD.
- Operator Number
- 10094272
- Address
- Aopheasang Village, Kandoeng Commune, Bati District, Takeo Province, Cambodia.
- City
- Bati District
- State
- Takeo
- Postal Code
- 210804
- Country
- KH
- Correspondent
- jianwen fei
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2025-11-20 |
| Bag, Stomal | GDS | Class 1 | Gastroenterology, Urology | No | 2025-11-20 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2025-11-20 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2025-11-20 |
| Device, Finger-Sucking | LQX | Class 1 | Physical Medicine | No | 2025-11-20 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-11-20 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-11-20 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2026-02-26 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Protector, Hearing (Circumaural) | EWE | Class U | Unknown | No | 2025-11-20 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2025-11-20 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2025-11-20 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2025-11-20 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2025-11-20 |
| Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | KFT | Class 1 | Physical Medicine | No | 2025-11-20 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2025-11-20 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Foot Wrap For Treating Restless Leg Syndrome Symptoms | OTX | Class 1 | Physical Medicine | No | 2025-11-20 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2025-11-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2025-11-20 |
| Tape, Camera, Surgical | FXN | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Helmet, Cranial, For Protective Use | NDA | Class 1 | Physical Medicine | No | 2025-11-20 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-11-20 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2025-11-20 |
| Assembly, Thigh/Knee/Shank/Ankle/Foot, External | KFX | Class 2 | Physical Medicine | No | 2025-11-20 |
Proprietary Names
DRESSING; Foam Wound Dressing; OCCLUSIVE; WOUND
Arm Guard
Ostomy Pouch; Stomal Bag
Dressing
Eye Shield, Protective Goggles
Finger Guard
ADHESIVE; Elastic Adhesive Bandage; Elastic Tape; First-aid case; Kinesio Tape; Kinesiology tape and Kinezio tape; TAPE
Knee Guard
Orthosis, Limb Brace
First Aid Kit
Face Mask, Face Shield, Eye Shield
Earflaps Guard
Jockstrap
Shoulder Pad
Chest Guard
Medical External Fixation Splint
Sterile Eye Pad
Disposable Face Mask; Disposable Surgical Mask; Medical Face Mask
Elbow Brace; Wrist Brace; Palm Guard
NECK STRAP /HEAD STRAP/ULTRA STRAP
Hydrocolloid Dressing
Leg Guard
Mouth Guard (Tooth protection)
Elastic Bandage
Non-woven Sugical Tape
Head Guard; Neck Guard
DRESSING; HYDROPHILIC; WOUND
Waist Guard; Athletic Guard; Back Guard
Sterile Gauze Sponges; Elbow Brace; Wrist Brace; Palm Guard; Ankle Support
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)