FDA Registration
Active
🇻🇳 Vietnam
GLX MEDICAL DEVICES COMPANY LIMITED
Reg #: 3038276119
·
FEI: 3038276119
·
Expires 2026
Products
15
Proprietary Names
15
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- GLX MEDICAL DEVICES COMPANY LIMITED
- Registration Number
- 3038276119
- FEI Number
- 3038276119
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Factory No.3 Lot E-12, Long Binh Industrial Park (LOTECO), Long Binh Ward
- City
- Bien Hoa Dong Nai
- Country
- VN
Owner / Operator
- Firm Name
- GLX MEDICAL DEVICES COMPANY LIMITED
- Operator Number
- 10093255
- Address
- Factory No.3 Lot E-12, Long Binh Industrial Park (LOTECO), Long Binh Ward
- City
- Bien Hoa
- State
- Dong Nai
- Postal Code
- 810000
- Country
- VN
- Correspondent
- Tina Zhou
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2026-02-11 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2025-04-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2025-04-20 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2026-02-11 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2025-04-20 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2025-04-20 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2025-04-20 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-04-20 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2026-02-11 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2025-04-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2025-04-20 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2025-04-20 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2025-04-20 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2025-04-20 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2025-04-20 |
Proprietary Names
Alcohol Prep Pad
Tongue Depressors (Sterile), Tongue Depressors (Non-Sterile)
ACCESSORY SURGICAL APPAREL: Single Use Medical Face Mask
Disposable Medical Brush
APPLICATOR ABSORBENT TIPPED STERILE; Specimen Collection Swab Sterile, Vaginal PH Swab
COVER, MATTRESS (MEDICAL PURPOSES)
COVER, SHOE, OPERATING-ROOM
Disinfectant, Medical Devices
Cotton Ball
Transport Swab
APPLICATOR, ABSORBENT TIPPED NON STERILE: Specimen Collection Swab Non-Sterile
CAP, SURGICAL
Protective Suit, SUIT, SURGICAL
APPLICATOR. ENT
Spoon, Ophthalmic
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)