Suzhou Hengxiang IMP. & EXP. Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 35 device types.
Suzhou Hengxiang IMP. & EXP. Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Cotton, Roll, Marker, Skin and 33 other device types. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | SUZHOU HENGXIANG IMP. & EXP. CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9680934 |
| FEI number | 3006993165 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 苏州恒祥进出口有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 18TH FL.INTERNATIONAL ECONOMY |
| Postal code | 215004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Endoscope Cleaning Brush, cleaning brush | 2016 | 43 |
| Accessory, Surgical Apparel | Class 1 | Face Mask, ear-loop, Non-woven Face Mask, Procedure Mask | 2009 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swabs | 2007 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | lemon glycerin swabs sterile, Allicator,absorbent tipped ,Sterile, Cotton applicators sterile | 2014 | 100 |
| Apron, Protective | Class 1 | Apron, Adult Bibs, Protective Apron | 2010 | 46 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Urine Bag, Leg Bag | 2006 | 47 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Sterile Leg Bag for Urine Collection | 2014 | 52 |
| Bandage, Cast | Class 1 | Bandage, Cast | 2006 | 81 |
| Bandage, Elastic | Class 1 | Elastic Bandage | 2005 | 280 |
| Bedding, Disposable, Medical | Class 1 | Underpad bedding, Medical Underpad, Disposible Underpad, UNDER PAD, BODY BAG | 2010 | 308 |
| Brush, Scrub, Operating-Room | Class 1 | Hand Brush | 2016 | 42 |
| Cap, Surgical | Class 1 | Cap, Disposable Nonwoven cap | 2026 | 178 |
| Clamp, Surgical, General & Plastic Surgery | Class 1 | Plastic Towel Clamp | 2009 | 16 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary Drainage Bags | 2014 | 51 |
| Cotton, Roll | Class 1 | Cotton Balls,Cotton Rolls,Cotton Strings,Cotton Pleats,Dental Cotton Rolls | 2020 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Cover, Booties, SHOECOVERS | 2006 | 176 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tong Depressor | 2007 | 100 |
| Drape, Surgical, Antimicrobial | Class 2 | Surgical Drape, O.R. Towel | 2010 | 39 |
| Dress, Surgical | Class 1 | Surgical Cap, Hair nets, Hairnet Cap, surgical, CPE GOWN | 2010 | 71 |
| Fiber, Medical, Absorbent | Class 1 | OR Towel | 2022 | 172 |
| First Aid Kit With Drug | Class N | Frist Aid Kit | 2008 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit without Drug | 2008 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Sponge, Nonresorbable for External Use, Tracheostomy Dressing, Gauze Sponge, Gauze Bandage, Gauze Roll, Gauze Sponge Non-woven | 2009 | 266 |
| Gown, Examination | Class 1 | Exam Gown, Isolation Gown | 2006 | 109 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Precision TDP Lamp, TDP Lamp | 2011 | 235 |
| Marker, Skin | Class 1 | Identification Wristbands,ID BRACELET | 2019 | 55 |
| Mask, Scavenging | Class 1 | Face Mask; Dust Mask; Carbon Mask, Paper or Non-woven | 2012 | 158 |
| Needle, Acupuncture, Single Use | Class 2 | Alpha Acupuncture Needles,, Fine Point Acupuncture Needles, acupuncture needles | 2012 | 33 |
| Non-Surgical Gown | Class 1 | Disposable Nonwoven Isolation Gown, GOWN | 2011 | 318 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | PRE-CUT Mask Shield | 2026 | 384 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigation Syringe | 2012 | 110 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Advantage Urinary Bags, Sterile, Urinary Drainage Bags, Sterile, Urinary Leg Bags, 600cc or 1000cc, Sterile | 2013 | 23 |
| Tape And Bandage, Adhesive | Class 1 | NON Woven Tape, Silk Tape, Medical Tape, Surgical Tape | 2006 | 353 |
| Toothbrush, Manual | Class 1 | Adult toothbrush,Kids toothbrush | 2021 | 244 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Feeding Bags,Enteral Delivery Pump Bag Set | 2020 | 25 |
Clearances
No clearance names Suzhou Hengxiang IMP. & EXP. Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K081720 | 2009-06-16 | ILY | Traditional | Prime Herbs Corporation |
| K082863 | 2009-01-09 | KNT | Traditional | Dynarex Corp. |
| K061517 | 2006-11-22 | MQX | Traditional | Prime Herbs Corporation |
| K052169 | 2005-11-17 | KKX | Traditional | Intl. Medsurg Connection, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Medical products, Textiles, Light industrial products |
|---|---|
| Export markets | More than 100 countries, with focus on EU, North America, Africa, and Japan |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.