Suzhou Sunmed Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 28 device types.
Suzhou Sunmed Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Finger Cot and 26 other device types. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | SUZHOU SUNMED CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005533873 |
| FEI number | 3005533873 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州舜康商贸有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | NO.88 SHISHAN ROAD, |
| Postal code | 215011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | penrose tube | 2022 | 33 |
| Accessory, Surgical Apparel | Class 1 | Gloves, disposable face mask | 2018 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Non-woven Swabs | 2014 | 186 |
| Bag, Ice | Class 1 | Instant Cold Pack | 2018 | 86 |
| Band Or Belt, Pelvic Support | Class 1 | Waist Support | 2016 | 54 |
| Bandage, Elastic | Class 1 | Medical Bandage,Elastic Bandage, Tubular Bandage, Cohesive Bandage, P.O.P Bandage, Stockinette Bandage, Wrist Band,Head Band, Socks | 2014 | 280 |
| Bedding, Disposable, Medical | Class 1 | Emergency blanket; Fire blanket | 2025 | 308 |
| Disinfectant, Medical Devices | Class 1 | Wipes, Alcohol Pad | 2016 | 197 |
| Dispenser, Solid Medication | Class 1 | Pill Box | 2016 | 68 |
| Dressing, Wound, Drug | Class U | RTD Wound Dressing; RTD Wound Dressing; DermaBlue Foam; Gentell Blue Foam Dressing; Vitale RTD Wound Dressing;, CuraBlue Silver Foam | 2019 | 48 |
| Dressing, Wound, Hydrophilic | Class 1 | First Aid Bandage, Sterile Wound Plaster, Wound Dressing; RTD Wound Dressing | 2014 | 195 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | disposable face mask | 2020 | 182 |
| Fiber, Medical, Absorbent | Class 1 | Absorbent gauze products | 2014 | 172 |
| Finger Cot | Class 1 | Finger Cot | 2020 | 29 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2018 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Non-Adherent Pad, Dressing Kit | 2014 | 266 |
| Insoles, Medical | Class 1 | GEL TOE Seperator, GEL Bunion Guard,gel Heel CUP, GEL Cushions,bunion TOE Spreader,heel Liners | 2015 | 34 |
| Joint, Ankle, External Brace | Class 1 | Ankle Support | 2016 | 134 |
| Joint, Knee, External Brace | Class 1 | Palm Support,Wrist Support,Elbow Support,Knee Support | 2016 | 137 |
| Orthosis, Limb Brace | Class 1 | Shin Support,Thigh Support, GEL Corn Protectors, GEL TOE Protector, TOE Bandages, TOE Wraps | 2015 | 144 |
| Pack, Hot Or Cold, Disposable | Class 1 | Cold And Hot Therapy Pack, Heat Pack | 2018 | 176 |
| Protector, Skin Pressure | Class 1 | GEL CALLUS REMOVERS, CORN REMOVER, Heel Ankle Protector, GEL TOE Spacers, Callus Cushion, Callus Remover, Corn Cushion, Bunion Cushion, Corn Remover, | 2015 | 101 |
| Shoe, Cast | Class 1 | post op shoe, heel wedge shoe, offloading shoe, soft night splint, hard night splint, cast shoe, shoe balancer, adjustable orthopedic knee braces | 2020 | 20 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Padded Splint | 2023 | 62 |
| Splint, Hand, And Components | Class 1 | Arthritis gloves; Compress gloves | 2024 | 144 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Compression Night Garment, Compression Day Garment, Compression Garment Socking | 2026 | 76 |
| Suit, Surgical | Class 1 | disposable face mask | 2020 | 74 |
| Tape And Bandage, Adhesive | Class 1 | Medical Adhesive Tape, Kineso Tape, Adhesive Sport Tape | 2014 | 353 |
Clearances
No clearance names Suzhou Sunmed Co., Ltd. as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K060832 | 2007-03-13 | FRO | Traditional | Retro-Tech, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 150+ |
| Factory area | 10000 m² |
| Main products | athletic tape, kinesiology tape, bandages, gauze, medical tape |
| Certifications | CE (MDR), FDA, ISO 13485:2016, Saudi Arabia SFDA |
| Export markets | UK, Germany, Spain, Denmark, Netherlands, Japan, Malaysia, Philippines, Thailand, Tanzania, Mauritius, South Africa, Australia, New Zealand |
| OEM and ODM | Offered |
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.