Shanghai Carelife International Trading Co., Ltd.
Registered establishment in Jinqiao Pudong, Shanghai, China. 11 device types, 2 clearances.
Shanghai Carelife International Trading Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Needle, Dental, Syringe, Piston and 9 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004143450 |
| FEI number | 3004143450 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 上海乐雅国际贸易股份有限公司 |
|---|---|
| Source | Zhihuiya company database |
Location
| City | Jinqiao Pudong |
|---|---|
| Province | Shanghai |
| Address | room 1707 Yinqiao Building |
| Postal code | 201206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | JJ Care | 2023 | 21 |
| Needle, Dental | Class 1 | Plasdent | 2013 | 56 |
| Needle, Hypodermic, Single Lumen | Class 2 | Medline pen needle, Caretouch, Livaclean Health Pen Needle, JJ Care PEN Needles | 2014 | 71 |
| Set, Administration, Intravascular | Class 2 | 2017 | 49 | |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Ultilet, Global Lancets, MEDICORE Lancets, Dynarex Safety Lancets, Medt, Caretouch | 2011 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | Advocate, JJ Care | 2023 | 21 |
| Syringe, Antistick | Class 2 | MedtPoint, JJ Care Insulin Syringe, JJ Care Insulin Syringe for Pets | 2016 | 39 |
| Syringe, Irrigating (Dental) | Class 1 | 2016 | 22 | |
| Syringe, Piston | Class 2 | MedtPoint, JJ Care Insulin Syringe, JJ Care Insulin Syringe for Pets, Caretouch | 2016 | 60 |
| Syringe, Restorative And Impression Material | Class 1 | Plastic utility tubes, Plastic cleaning tips, Plastic tips | 2013 | 49 |
| Wrap, Sterilization | Class 2 | 2014 | 38 |
Clearances
2 clearances name Shanghai Carelife International Trading Co., Ltd. as applicant. 8 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 |
|---|---|---|---|---|
| K221383 | 2022-09-21 | QRK | Traditional | This company |
| K131954 | 2014-05-29 | FMI | Traditional | This company |
| K220475 | 2022-07-06 | QRL | Traditional | Tianjin Huahong Technology Co., Ltd. |
| K152808 | 2016-03-25 | MEG | Traditional | U&U Medical Technology Co., Ltd. |
| K151151 | 2015-09-24 | FPA | Traditional | U&U Medical Technology Co., Ltd. |
| K142765 | 2015-08-11 | FMI | Traditional | Thinkmed Medical Technology Co., Ltd. |
| K131531 | 2014-05-12 | MEG | Traditional | Anhui Tiankang Medical Products Co., Ltd. |
| K132553 | 2014-02-27 | FMF | Traditional | U&U Medical Technology Co., Ltd. |
| K123162 | 2014-02-26 | FRG | Traditional | U&U Medical Technology Co., Ltd. |
| K132552 | 2013-11-13 | FMI | Traditional | U&U Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Diabetes care products, Injection products, Catheters |
| Export markets | US |
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.