FDA Registration
Active
🇹🇭 Thailand
Jenius Medical Sci-Tech (Thailand) Co., Ltd.
Reg #: 3042896810
·
FEI: 3042896810
·
Expires 2026
Products
27
Proprietary Names
46
Establishment Types
2
Classifications
27
Registration Details
- Registration Name
- Jenius Medical Sci-Tech (Thailand) Co., Ltd.
- Registration Number
- 3042896810
- FEI Number
- 3042896810
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 868-2 Moo 6, Nong Yai Subdistrict,
- City
- Nong Yai District, Chon Buri
- Country
- TH
Owner / Operator
- Firm Name
- Jenius Medical Sci-Tech (Thailand) Co., Ltd.
- Operator Number
- 10094893
- Address
- 868-2 Moo 6, Nong Yai Subdistrict,
- City
- Nong Yai District
- State
- Chon Buri
- Postal Code
- 20190
- Country
- TH
US Agent
- Business Name
- Medapproval LLC
- Contact Name
- William Slevin
- Address
- 730 E Suber Rd
- City
- Greer
- State
- SC
- ZIP
- 29650
- Country
- US
- [email protected]
- Phone
- 404 5935005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2026-01-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2026-01-03 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2026-01-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Exerciser, Non-Measuring For Stroke Rehabilitation | PKS | Class 1 | Physical Medicine | No | 2026-01-03 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2026-01-03 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2026-01-03 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2026-01-03 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2026-01-03 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2026-01-03 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2026-01-03 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2026-01-03 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-01-03 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2026-01-03 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2026-01-03 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2026-01-03 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2026-01-03 |
Proprietary Names
Isolation/Surgical Suit
Drape Urological
Bandage
Sterile Eye Wash
Normal Saline
Safety Pin
Non-Adherent Pad and Dressing
Exercise Non-Measuring
Cotton Tip Applicators/Cotton Swabs
Cotton Wool Ball/Cotton Ball
Oxygen Mask
CPR Face Shield Mask
Bite Block
Tongue Depressor
Water Bottle
Water Cup
Cleaning Wipe
First Aid Kit
Face Mask
Gloves
Examination
Patient
TPE Cover
Surgical Cap
Disposable Mask
Flashlight
Tweezers/Forceps
Non-Woven Tape/Medical Tape/First Aid Roll
Adhesive Bandage/Adhesive Strips/ Fabric
Hydrocolloid Blister Plaster
Moleskin Blister Relief Pad
Hydrocolloid Dressing
Non-Adherent Wound Pad/Gauze Pad
Absorbent Pad/ABD Pad
Gauze/Sterile Sponges/Sterile Pad
Gauze Roll/Dressing Compression
Adhesive Wound Dressing
Scissors
Emergency Blanket
Shoe Cover
Tourniquet
Eye Pad
Ice Pack
Cooling Gel Sheet
Ice Bag
Triangular Bandage
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device