FDA Registration
Active
🇨🇳 China
SUZHOU HENGXIANG IMP. & EXP. CO., LTD
Reg #: 9680934
·
FEI: 3006993165
·
Expires 2026
Products
34
Proprietary Names
43
Establishment Types
1
Classifications
34
Registration Details
- Registration Name
- SUZHOU HENGXIANG IMP. & EXP. CO., LTD
- Registration Number
- 9680934
- FEI Number
- 3006993165
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18TH FL.INTERNATIONAL ECONOMY, AND TRADE BUILDING, 1638 XIHUAN RD.
- City
- SUZHOU Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K061517
Owner / Operator
- Firm Name
- SUZHOU HENGXIANG IMP. & EXP. CO., LTD
- Operator Number
- 9010435
- Address
- 18TH FL.INTERNATIONAL ECONOMY, & TRADE BUILDING, 1638 XIHUAN RD.
- City
- SUZHOU,
- State
- Jiangsu
- Postal Code
- 215004
- Country
- CN
- Correspondent
- ZHONG - WEI
US Agent
- Business Name
- Busse Hospital Disposables
- Contact Name
- Brenda Rojas
- Address
- 75 Arkay Drive
- City
- Hauppauge
- State
- NY
- ZIP
- 11788
- Country
- US
- [email protected]
- Phone
- 631 4354711
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2009-08-18 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2006-03-08 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2019-03-04 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2006-03-08 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-11-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2009-09-24 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2014-05-14 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2013-11-19 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2008-09-24 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2009-10-13 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2014-02-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2010-07-21 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2006-07-06 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2006-07-06 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2026-04-13 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2012-11-28 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2020-05-14 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2021-07-07 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2012-01-16 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2008-09-24 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2006-03-08 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2011-10-05 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2010-07-21 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-07-02 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-11-06 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2014-05-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-02-27 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2011-05-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-10-27 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2010-07-21 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2010-01-11 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2007-07-02 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2016-11-07 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2022-08-02 |
Proprietary Names
Gauze Sponge, Nonresorbable for External Use, Tracheostomy Dressing
Shoe Cover, Booties, SHOECOVERS
Identification Wristbands,ID BRACELET
NON WOVEN TAPE, SILK TAPE, MEDICAL TAPE, SURGICAL TAPE
ENDOSCOPE CLEANING BRUSH
cleaning brush
Face Mask, ear-loop, Non-woven Face Mask, Procedure Mask
URINARY DRAINAGE BAGS
Urinary Drainage Bags, Sterile
Urinary Leg Bags, 600cc or 1000cc, Sterile
Advantage Urinary Bags, Sterile
Frist Aid Kit
Plastic Towel Clamp
lemon glycerin swabs sterile
Allicator,absorbent tipped ,Sterile
Cotton applicators sterile
Underpad bedding, Medical Underpad, Disposible Underpad, UNDER PAD, BODY BAG
EXAM GOWN, ISOLATION GOWN
Urine Bag, Leg Bag
Cap, Disposable Nonwoven cap
Fine Point Acupuncture Needles
Alpha Acupuncture Needles,
acupuncture needles
Cotton Balls,Cotton Rolls,Cotton Strings,Cotton Pleats,Dental Cotton Rolls
Adult toothbrush,Kids toothbrush
Face Mask; Dust Mask; Carbon Mask, Paper or Non-woven
First Aid Kit without Drug
Bandage, Cast
TDP Lamp
Precision TDP Lamp
Surgical Cap, Hair nets, Hairnet Cap, surgical, CPE GOWN
Cotton Swabs
Irrigation Syringe
Sterile Leg Bag for Urine Collection
Feeding Bags,Enteral Delivery Pump Bag Set
Disposable Nonwoven Isolation Gown, GOWN
Elastic Bandage
Apron, Adult Bibs, Protective Apron
Surgical Drape, O.R. Towel
Tong Depressor
Gauze Sponge, Gauze Bandage, Gauze Roll, Gauze Sponge Non-woven
HAND BRUSH
OR TOWEL
Establishment Types
Export Device to the United States But Perform No Other Operation on Device