Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010339057

FEI Number

3010339057

Entity Name

SUZHOU TEXNET

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Rm.1103-1104, 11/F, Block A, Xin Tian Xiang Bldg, Suzhou Jiangsu 215021, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Suzhou Texnet (Owner Number: 10057231)

Owner / Operator Contact Address

Rm.1103-1104, 11/F, Block A, Xin Tian Xiang Bldg, Suzhou, CN-NOTA 215021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Apparel, Surgical Suzhou Texne Flow Rate Measuring Catheter, Irrigation Suzhou Texnet Eye Shield Bag, Urine Collection Gown, examination Suzhou Texnet Eye Pad Syringe, Ent Utensil eating Suzhou Texnet Dressing Wound _Hydrophilic First Aid Kit respirator BASIN, EMESIS Bandage Clamp Bandage, Elastic Applicator, Absorbent Tip Pad, Alcohol Brusc, Cleaning Suzhou Texnet Cathether Tape, Bandage, Adhesive Suction Catheter Drape, Surgical Container Specimen BRUSH, DERMABRASION, Depressor, Tongue BEDPAN Catheter, Retention Suzhou Texnet Camera Tape Suzhou Medical Foam Surgical Suit Tape, Adhesive Stocking, Medical Bath, sitz

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-15
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2024-10-22
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2018-03-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-10-22
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-03-12
FME	Gown, Examination	General Hospital	Class 1	880.6265	2018-03-14
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-10-22
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-03-12
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2026-04-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-10-22
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-03-14
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-29
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2026-04-26
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-03-14
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2019-08-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-03-11
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-03-14
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2018-03-14
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2018-03-12
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-10-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-03-14
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2018-03-12
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-03-14
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2026-04-26
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2024-03-11
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2018-03-12
FOB	Bedpan	General Hospital	Class 1	880.6730	2026-04-26
FGD	Catheter, Retention, Barium Enema With Bag	Gastroenterology, Urology	Class 2	876.5980	2018-03-12
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2024-10-22
NNT	Punch, Gelfoam, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2025-03-27
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-24
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2018-03-14
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2018-03-12
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2026-04-26

Official Correspondent

David Wu

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Suzhou Texnet

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

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.

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010339057. Last updated year: 2026. Please use registration number 3010339057 when referencing this establishment in official correspondence.