Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 14 device types, 1 product catalogued.
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Lumbar, Pack, Heat, Moist and 12 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
14device types registered with the FDA
1product
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005023997 |
| FEI number | 3005023997 |
| DUNS | 546872672 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 上海创始医疗科技（集团）股份有限公司 |
|---|---|
| Unified social credit code | 91310000607498706F |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No.388, Zhangliantang Road, Qingpu |
| Postal code | 201716 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | RITECARE Medical Specimen Bag ASP081, ASP082, ASP083, ASP084, RITECARE Spill kit Bag ASP086, RITECARE Biohazard Bag ASP070, ASP071, ASP072, ASP073, ASP074, ASP075, ASP076, ASP077, ASP078, ASP079, RITECARE Stool Disposal Bag ASP087, ASP088, ASP089, RITECARE Vomiting Bag ASP090, RITECARE Autoclave Bag ASP060, ASP061, ASP062, ASP063, ASP064, ASP065, ASP066, ASP067, ASP068, ASP069 | 2020 | 51 |
| Device, Intravascular Catheter Securement | Class 1 | PICC Sleeve, Pediatric Sleeve, IV Sleeve | 2016 | 33 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Gel | 2025 | 85 |
| Insulin Vial Protector/Holder | Class 1 | Ice Gel Pack (Insulin Protector) NCCLB, NCDDO, NCDPC, NCDPD, NCDPX, NCGPL, NCGPS, Ice Gel Pack (Insulin Protector) NCIPL, NCIPM, NCIPN, NCIPS, NCPPN, NCEVA, NCTDM, NCTDL | 2019 | 7 |
| Joint, Ankle, External Brace | Class 1 | Joint, Ankle, External | 2012 | 134 |
| Joint, Knee, External Brace | Class 1 | universal brace | 2012 | 137 |
| Nursing Pad, Hydrogel | Class 1 | 2023 | 15 | |
| Orthosis, Cervical | Class 1 | 2021 | 114 | |
| Orthosis, Lumbar | Class 1 | universal brace | 2012 | 110 |
| Pack, Heat, Moist | Class 1 | HOT Pack (Disposable), HOT Pack Reusable, IV Sleeve | 2006 | 39 |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant Perineal Cold Pack, HOT OR Cold Pack Reusable, Multilple, Clay Pack, Disposable perineal cold pad, Instant cold pack and 6 more | 2005 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | ICE GEL Pack, moist heat back wrap, Clay Pack, Moist heat pad, Heated Seat Warmer, Forever Cool Small Mat and 26 more | 2006 | 178 |
| Protector, Skin Pressure | Class 1 | intelligent anti-bedsore cushion | 2021 | 101 |
| Tape And Bandage, Adhesive | Class 1 | 2026 | 353 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Cramer | IMD | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Factory area | 83000 m² (two production bases; GMP workshop 8500 m²) |
| Main products | Medical dressings, Hydrogels, Cold chain packaging, Thermal therapy products, Disinfection products |
| Certifications | ISO13485, ISO22716, ISO9001, ISO50001, ISO14001, ISO45001, Japan MHLW, cGMP, EU CE IIa, US FDA NDC |
| Export markets | USA, UK, Thailand, International |
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.