Data / Medical devices / China / Nanjing Anjian Medical Device Co.,ltd.
Nanjing Anjian Medical Device Co.,ltd.: FDA-registered device maker in Nanjing Jiangsu, China, 15 510(k) clearances
Nanjing Anjian Medical Device Co.,ltd. is registered with the FDA (registration 3015142802) in Nanjing Jiangsu, China. It lists 22 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015142802
- Address
- Building 9 No. 16 Xinggu Road Guli Street Jiangning District, Nanjing Jiangsu, China, 211100
- Owner or operator
- Nanjing Anjian Medical Device Co.,Ltd. (10059266)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- December 16, 2018
- Registered through
- 2026
- Brand names listed
- Adhesive remover wipe, Alcohol Pad, Alcohol Prep Pad, Alginate Dressing, Antimicrobial Gauze, Antimicrobial Gauze Wound Dressing, Bordered Gauze, Catheter Insertion Tray and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 2, 2021 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | MEG | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 13, 2019 | K181478 | Roosin Xeroform Petrolatum Dressing | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| September 6, 2019 | K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | MEG | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 14, 2019 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| June 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | FRO | Substantially Equivalent | Roosin Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 28, 2014 | K142563 | Well Lead PVC Urethral Catheter | EZD | Substantially Equivalent | Well Lead Medical Co., Ltd. | accessdata.fda.gov |
| October 3, 2013 | K130908 | DISPOSABLE SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Guangdong Baihe Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 10, 2012 | K112110 | STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | Jianerkang Medical Dressing Company | accessdata.fda.gov |
| February 13, 2012 | K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, | GBM | Substantially Equivalent | Hangzhou Bever Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| May 23, 2003 | K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030664 | AMSURE FOLEY INSERTION TRAY | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Ostomy
- All makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Dressing, Wound, Drug
Updated July 2, 2021. 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.