Data / Medical devices / China / Ningbo Caremed Medical Products Co Ltd
Ningbo Caremed Medical Products Co Ltd: FDA-registered device maker in Ningbo Zhejiang, China, 4 510(k) clearances
Ningbo Caremed Medical Products Co Ltd is registered with the FDA (registration 3009498548) in Ningbo Zhejiang, China. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 28, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009498548
- Address
- No 79 Jiutang Rd, South side Hangzhou Bay New Zone, Ningbo Zhejiang, China, 315336
- Owner or operator
- NINGBO CAREMED MEDICAL PRODUCTS CO LTD (10038943)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 27, 2011
- Registered through
- 2026
- Brand names listed
- ADVOCATE, Easy Glide, JJ CARE Insulin Pen Needle, Lite touch, LivaClean Health Insulin Pen Needle, Medeco, Medline pen needle, Medt and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 28, 2024 | K242622 | Sterile Lancets for Single Use | QRK | Substantially Equivalent | Ningbo Caremed Medical Products Co., Ltd. | accessdata.fda.gov |
| August 20, 2024 | K241848 | MedtFine Safety Lancet | FMK | Substantially Equivalent | Ningbo Caremed Medical Products Co., Ltd. | accessdata.fda.gov |
| September 21, 2022 | K221383 | MedtFine Blood Lancet | QRK | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
| May 29, 2014 | K131954 | MEDI PEN NEEDLE | FMI | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- 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
- 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
Updated October 28, 2024. 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.