Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023855650

FEI Number

3023855650

Entity Name

NANNING SIXTANT BIOTECHNOLOGY CO., LTD

City/State/Country

Nanning Guangxi, CN

Establishment Address

First floor , No.5 Research and Development plant, Zhiyuan technology enterprise incubation base, No. 27, Anping Road, Wuming District, Nanning Guangxi 530100, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Nanning Sixtant Biotechnology Co., Ltd (Owner Number: 10085641)

Owner / Operator Contact Address

First floor , No.5 Research and Development plant, Zhiyuan technology enterprise incubation base, No. 27, Anping Road, Wuming District, Nanning, CN-GX 530100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Band-Aid Essential oil for warming uterus Essential oil of anti-gasteremphraxis Medical adhesive Prosthetic Adhesive Acne patch Acne gel Nasal washer Manual Nasal Irrigator Electric Nasal Irrigator Self-adhesive silicone tape Silicone gel scar patch SCT-40mm*120cm Silicone gel scar patch SCT-40mm*240cm TAREGT CONTROL U.K LTD Silicone gel scar patch Silicone gel scar patch SCC-40mm*240cm Silicone gel scar patch SCC-40mm*240cm Silicone gel scar patch SCT-40mm*240cm Silicone scar gel Silicone gel scar patch TAREGT CONTROL U.K LTD Silicone gel scar patch SCT-40mm*120cm Cooling Paste Cooling gel Silicone Foam Dressing Water flosser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-01-03
IJZ	Oil, Clearing	Pathology	Class 1	864.4010	2023-03-22
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	Class 1	878.3800	2024-08-09
KLH	Antisera, C. Acnes	Microbiology	Class 1	866.3140	2023-03-17
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-07-03
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2023-03-17
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-03-17
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-07-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-03-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-01-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-07-03

Official Correspondent

Baiyin He

US Agent Details

Emilie Davis Email: safjiofewiwds@wilson.ntesmail.com Phone: (818) 5797288

Related Public Records

Same Entity

Nanning Sixtant Biotechnology 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023855650. Last updated year: 2026. Please use registration number 3023855650 when referencing this establishment in official correspondence.