Suzhou Acmed Import & Export Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 27 device types.
Suzhou Acmed Import & Export Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Sling, Arm, Basin, Emesis and 25 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | SUZHOU ACMED IMPORT & EXPORT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006538822 |
| FEI number | 3006538822 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 苏州鼎康进出口有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 436 Changjiang Road |
| Postal code | 215011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Accessories, Cleaning Brushes, FOR Endoscope | 2015 | 43 |
| Accessory, Surgical Apparel | Class 1 | Patient Drapes | 2008 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Applicator, Absorbent Tipped, NON-Sterile | 2011 | 186 |
| Bandage, Elastic | Class 1 | Bandage; Elastic; Prem-Weave; Ultra-Weave; Compress Bandage; Compress Gauze Bandage, Krinkle Gauze Roll | 2008 | 280 |
| Basin, Emesis | Class 1 | Basin, Emesis | 2023 | 65 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical | 2008 | 308 |
| Catheter, Continuous Irrigation | Class 1 | Catheter, Continuous Irrigation | 2008 | 6 |
| Clamp, Surgical, General & Plastic Surgery | Class 1 | Towel Clamp | 2008 | 16 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary Drainage Bags AND Urinary LEG | 2025 | 51 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Cover, Terry Treads; Slipper S | 2010 | 176 |
| Drape, Surgical, Antimicrobial | Class 2 | Surgical Drape | 2009 | 39 |
| Dressing, Wound, Occlusive | Class 1 | Sterile hydrocolloid dressing | 2017 | 183 |
| Fiber, Medical, Absorbent | Class 1 | Surgical Towel | 2008 | 172 |
| Forceps, General & Plastic Surgery | Class 1 | Forceps | 2008 | 27 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Border Gauze Sponges; Cotton; NON-Woven | 2008 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Gauze; LAP AND Vaginal Sponges | 2008 | 67 |
| Gown, Surgical | Class 2 | Surgical Gowns | 2009 | 68 |
| Instrument, Surgical, Disposable | Class 1 | 2015 | 45 | |
| Mask, Gas, Anesthetic | Class 1 | Disposable Face Mask | 2010 | 71 |
| Operating Room Accessories Table Tray | Class 1 | Sheets-Drapes; Stand & Equipment Covers | 2008 | 25 |
| Scissors, Umbilical | Class 1 | Umbilical Cord Clamp Cutter | 2017 | 9 |
| Sling, Arm | Class 1 | Triangular Bandage | 2018 | 126 |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal Speculums | 2017 | 40 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Cotton; Stockinette | 2008 | 76 |
| Syringe, Irrigating (Non Dental) | Class 1 | Bulb; EAR Syringe; Irrigation | 2008 | 110 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Enteral Feeding Gravity Bag Set, Enteral Delivery Pump Set, Enteral Delivery Pump Set; Enteral Delivery Pump Bag Set;Enteral Feeding Gravity Bag Set, Enteral Delivery Pump Bag Set | 2025 | 25 |
| Tubing, Noninvasive | Class 2 | Tubing, Noninvasive | 2011 | 33 |
Clearances
No clearance names Suzhou Acmed Import & Export Co., Ltd. as applicant. 3 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 |
|---|---|---|---|---|
| K082863 | 2009-01-09 | KNT | Traditional | Dynarex Corp. |
| K070432 | 2007-09-24 | KKX | Traditional | Welmed, Inc. |
| K070431 | 2007-05-24 | FYA | Traditional | Welmed, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Surgical dressing, Medical disposables, Personal protective equipment, Lab consumables |
|---|---|
| Export markets | Multiple regions (20 years export experience) |
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.