Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039440874

FEI Number

3039440874

Entity Name

ZHONGSHAN XINWEI WEAVING CO., LTD.

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

30#Jinhong Rd, Pingnan Industrial Zone, Sanxiang Town, Zhongshan Guangdong 528463, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongshan Xinwei Weaving Co., Ltd. (Owner Number: 10094811)

Owner / Operator Contact Address

30#Jinhong Rd, Pingnan Industrial Zone, Sanxiang Town, Zhongshan, CN-GD 528463, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VTAPE, TOURNIQUET, NONPNEUMATIC (Tourniquet, Silicone tourniquet), Model: ZXD-01, ZXD-02, ZXD-03, ZXD-04, ZXD-05 VTAPE, Catheter Fixation Device, Model: C1, C2, C3, C4, C5, C6, C7, C8, C9, C10 VTAPE, Catheter Fixation Device, Model: A1, A2, A3, A4, A5, A6, A7, A8, A9, A10, B1, B2, B3, B4, B5, B6, B7, B8, B9, B10 KOEYNUE, CPAP replacement headgear and accessories, Model: CP-N30i, CP-F30i, CP-FX, CP-PH1, CP-PH2, CP-PH3,CP-PH4,CP-PH5 VTAPE, CPAP replacement headgear and accessories, Model: RSM-04, RSM-05, RSM-06, RSM-07, RSM-08, RSM-09 Wellempire, CPAP replacement headgear and accessories, Model: CP-N30i, CP-F30i, CP-FX, CP-PH1, CP-PH2, CP-PH3, CP-PH4 KOEYNUE, CPAP replacement headgear and accessories, Model: RSM-04, RSM-05, RSM-06, RSM-07, RSM-08, RSM-09 KOEYNUE, CPAP replacement headgear and accessories, Model: CP-N20, CP-F20, CP-P10, CP-F30, CP-F40, CP-P10i, CP-N30 Wellempire,CPAP replacement headgear and accessories,Model:RSM-02, RSM-03,RSM-04, RSM-05, RSM-06, RSM-07, RSM-08, RSM-09 Wellempire, CPAP replacement headgear and accessories, Model: CP-PH5, CP-PH6, CP-FP1, CP-FP2, CP-FP3, CP-FP4, RSM-01 VTAPE, CPAP replacement headgear and accessories, Model: CP-PH6, CP-FP1, CP-FP2, CP-FP3, CP-FP4, RSM-01, RSM-02, RSM-03 KOEYNUE, CPAP replacement headgear and accessories, Model:CP-PH6, CP-FP1, CP-FP2, CP-FP3, CP-FP4, RSM-01, RSM-02, RSM-03 VTAPE, CPAP replacement headgear and accessories, Model: CP-N30i, CP-F30i, CP-FX, CP-PH1, CP-PH2, CP-PH3, CP-PH4, CP-PH5 VTAPE, CPAP MASK,OXYGEN, Model: BMZ-01,BMZ-02,BMZ-03,BMZ-04,KBZ-01,KBZ-02,KBZ-03,KBZ-04,KBZ-05,QNM-01,QNM-02,QNM-03 Wellempire, CPAP replacement headgear and accessories, Model: CP-N20, CP-F20, CP-P10, CP-F30, CP-F40, CP-P10i, CP-N30 VTAPE, CPAP replacement headgear and accessories, Model: CP-N20, CP-F20, CP-P10, CP-F30, CP-F40, CP-P10i, CP-N30 Wellempire, Medical Fixation Strips, Model: E1, E2, E3, E4, E5, E6, E7, E8, E9, E10, F1, F2, F3, F4, F5, F6, F7, F8, F9, VTAPE, Medical Fixation Strips, Model: E1, E2, E3, E4, E5, E6, E7, E8, E9, E10, F1, F2, F3, F4, F5, F6, F7, F8, F9, F10 VTAPE, Medical Fixation Strips, Model: G1, G2, G3, G4, G5, G6, G7, G8, G9, G10, H1, H2, H3, H4, H5, H6, H7, H8, H9, H10 Wellempire, Medical Fixation Strips, Model: G1, G2, G3, G4, G5, G6, G7, G8, G9, G10, H1, H2, H3, H4, H5, H6, H7, H8, H9, VTAPE, Self-adhesive silicone tape, Model: T1, T2, T3, T4, T5, T6, T7, T8, T9, T10 VTAPE, Medical Adhesive bandage, Model: D1, D2, D3, D4, D5, D6, D7, D8, D9, L1, L2, L3, L4, L5, L6, L7, L8, L9

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2025-12-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-24
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2025-12-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-12-24
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-24

Official Correspondent

Jingliang Liu

US Agent Details

Tang Thomas Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Zhongshan Xinwei Weaving 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039440874. Last updated year: 2026. Please use registration number 3039440874 when referencing this establishment in official correspondence.