GUANG XI FULAIMING BIOPHARMACEUTICS CO., LTD.

FDA Device Registration & Listing · Nanning Guangxi, CN · Registration 3038624837

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038624837
FEI Number
3038624837
Entity Name
GUANG XI FULAIMING BIOPHARMACEUTICS CO., LTD.
City/State/Country
Nanning Guangxi, CN
Establishment Address
4th Floor, Building 14, No. 19, East Guokai Avenue, Nanning City, Guangxi Province, China, Nanning Guangxi 530031, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Guang Xi FuLaiMing Biopharmaceutics Co., Ltd. (Owner Number: 10093515)
Owner / Operator Contact Address
4th Floor, Building 14, No. 19, East Guokai Avenue, Nanning City, Guangxi Province, China, Nanning, CN-GX 530031, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KZR Chromatography (Liquid, Gel), Clinical Use Clinical Chemistry Class 1 862.2260 2025-05-28
JEW Tip, Rubber, Oral Hygiene Dental Class 1 872.6650 2025-05-28
IBG Trypsin Pathology Class 1 864.4400 2025-05-28
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2025-11-20
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-05-28
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2025-05-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-05-28
MAU Eraser, Dental Stain Dental Class 1 872.6855 2025-05-28
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2025-05-28
MHW Dressing, Compression General Hospital Class 1 880.5075 2025-05-28

Official Correspondent

Xian Yi

US Agent Details

Wilson Li Business: REPF America LLC Email: qagujdsvvt@outlook.com Phone: (719) 2013315

Related Public Records

Same Entity

Guang Xi FuLaiMing Biopharmaceutics Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038624837. Last updated year: 2026. Please use registration number 3038624837 when referencing this establishment in official correspondence.
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