Data / Medical devices / China / Shanghai Carelife International Trading Co. Ltd
Shanghai Carelife International Trading Co. Ltd: FDA-registered device maker in Jinqiao Pudong Shanghai, China, 10 510(k) clearances
Shanghai Carelife International Trading Co. Ltd is registered with the FDA (registration 3004143450) in Jinqiao Pudong Shanghai, China. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004143450
- Address
- room 1707 Yinqiao Building No 58, Jinxin Road, Jinqiao Pudong Shanghai, China, 201206
- Owner or operator
- Shanghai Carelife International Trading Co. LTD (10035047)
- Roles
- Exporter to the US, Specification developer
- First device listed
- January 28, 2011
- Registered through
- 2027
- Brand names listed
- Advocate, CARETOUCH, Dynarex Safety Lancets, Global Lancets, JJ CARE, JJ CARE PEN NEEDLES, JJ Care Insulin Syringe, JJ Care Insulin Syringe for Pets and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2022 | K221383 | MedtFine Blood Lancet | QRK | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| March 25, 2016 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| September 24, 2015 | K151151 | U & U Intravascular Administration Set | FPA | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| August 11, 2015 | K142765 | TM SAFETY NEEDLE | FMI | Substantially Equivalent | Thinkmed Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 29, 2014 | K131954 | MEDI PEN NEEDLE | FMI | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
| May 12, 2014 | K131531 | TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE | MEG | Substantially Equivalent | Anhui Tiankang Medical Products Co., Ltd. | accessdata.fda.gov |
| February 27, 2014 | K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | FMF | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| February 26, 2014 | K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| November 13, 2013 | K132552 | U&U STERILE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Dental
- All makers of Syringe, Irrigating (Dental)
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated September 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.