FDA Registration
Active
🇨🇳 China
GUANG XI FULAIMING BIOPHARMACEUTICS CO., LTD.
Reg #: 3038624837
·
FEI: 3038624837
·
Expires 2026
Products
12
Proprietary Names
23
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- GUANG XI FULAIMING BIOPHARMACEUTICS CO., LTD.
- Registration Number
- 3038624837
- FEI Number
- 3038624837
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4th Floor, Building 14, No. 19, East Guokai Avenue, Nanning City, Guangxi Province, China
- City
- Nanning Guangxi
- Country
- CN
Owner / Operator
- Firm Name
- Guang Xi FuLaiMing Biopharmaceutics Co., Ltd.
- Operator Number
- 10093515
- Address
- 4th Floor, Building 14, No. 19, East Guokai Avenue, Nanning City, Guangxi Province, China
- City
- Nanning
- State
- Guangxi
- Postal Code
- 530031
- Country
- CN
- Correspondent
- Xian Yi
US Agent
- Business Name
- REPF America LLC
- Contact Name
- Wilson Li
- Address
- 6510 S Academy Blvd
- City
- Co Spgs
- State
- CO
- ZIP
- 80916
- Country
- US
- [email protected]
- Phone
- 719 2013315
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chromatography (Liquid, Gel), Clinical Use | KZR | Class 1 | Clinical Chemistry | No | 2025-05-28 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2025-05-28 |
| Trypsin | IBG | Class 1 | Pathology | No | 2025-05-28 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2025-11-20 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-05-28 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2025-05-28 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-05-28 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2025-05-28 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-05-28 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2025-05-28 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-05-28 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2025-05-28 |
Proprietary Names
(HPV) (Anti-HPV Gel):1.6g/ piece, 2g/ piece, 2.5g/ piece, 3g/ piece, 3.5g/ piece, 4g/ piece
(Oral Dressing):15g, 30g, 60g, 80g, 90g, 100g, 110g, 120g, 130g, 140g per bottle
3. Recombinant Collagen Vaginal Gel (Type l: 2/2.5/3 g/piece, Type ll: 3/4/5 g/bottle, Type lll: 6/10/20 g/piece)
2. Recombinant Collagen Hydrogel Dressing (A type: 2.5/3 g/stick, B type: 5/10/20/30/60/80/100/200 g/bottle);
1. Recombinant Collagen Repair Patch: 15/26/30 g/patch;
Vaginal Suppository :0.8g/tube, 1.15g/tube, 1.5g/tube
Oral Care Dressing: 15g, 30g, 60g, 80g, 90g, 100g per tube
(Type I Collagen Gel Dressing):3g/ piece
(HPV) (Anti-HPV Dressing):1.6g, 2g, 2.5g, 3g, 3.5g, 4g per tube
2. Recombinant Collagen Dressing: l type: 6/10/20/30/50 g/stick;
ll type: 5/10/20/30/50/60/80/100 g/bottle; III type: 10/20/25/30 g/piece (F-square, O-round, Y-unique)
1. Vaginal And Cervical Gel Dressing: 2/2.5/3/4/5 g/stick;
100g/ piece, 110g/ piece, 120g/ piece, 130g/ piece, 140g/ piece
(Desensitizing Toothpaste):15g/ piece, 20g/ piece, 30g/ piece, 60g/ piece, 80g/ piece, 90g/ piece,
Wound Dressing: 3g/tube,6g/tube,10g/tube
(Liquid Wound Dressing):20ml/bottle, 25ml/bottle, 30ml/bottle, 50ml/bottle, 100ml/bottle
(Recombinant Mucoprotein Hemorrhoid Dressing):0.8g /piece, 1.15g /piece, 1.5g /piece
(Vaginal Tamponade Dressing):2g/ plug, 2.5g/ plug, 3g/ plug
(Human Body Lubricant):10ml, 20ml per bottle
Lubricant: 3ml, 5ml, 10ml, 15ml, 20ml, 30ml, 50ml, 100ml, 200ml per bottle or stick
(Hemorrhoid Repair Gel):2g/ tube, 2.5g/ tube, 3g/ tube, 6g/ tube, 10g/ tube
(Rejuvenating Feminine Gel):2g, 2.5g, 3g per tube
(Scar Repair Creams):10g, 15g, 20g, 30g, 40g, 50g, 60g/piece
Establishment Types
Manufacture Medical Device