Data / Medical devices / Thailand / Nipro (Thailand) Corporation Limited
Nipro (Thailand) Corporation Limited: FDA-registered device maker in SENA Phra Nakhon Si Ayutthaya, Thailand, 18 510(k) clearances
Nipro (Thailand) Corporation Limited is registered with the FDA (registration 8041145) in SENA Phra Nakhon Si Ayutthaya, Thailand. It lists 12 device types. The FDA files 18 510(k) clearances under its listings, the newest dated May 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8041145
- FEI number
- 3002974635
- Address
- 10/2 Moo 8, Bangnomko, SENA Phra Nakhon Si Ayutthaya, Thailand, 13110
- Owner or operator
- NIPRO CORPORATION (8030375)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 6, 2006
- Registered through
- 2026
- Brand names listed
- BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Hold, NIPRO BioHole Needle with CAPICK, NIPRO SAFETOUCH IV CATHETER, NIPRO SAFETOUCH IV CATHETER winged, NIPRO Transducer Protector TP-SURE, Nipro SafeTouch II Gamma, Nipro SafeTouch II Safety AVF, Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle 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 |
|---|---|---|---|---|---|---|
| May 25, 2023 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | FMI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| July 19, 2019 | K182940 | Surdial DX Hemodialysis System | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| March 8, 2017 | K161681 | Nipro SafeTouch IV Catheter | FOZ | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| August 28, 2013 | K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) | FMF | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| February 14, 2013 | K130049 | MONOJECT 12ML SYRINGE | FMF | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 18, 2012 | K113471 | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET | FPA | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 18, 2012 | K113469 | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE | FMI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 17, 2012 | K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET | FPA | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| September 28, 2012 | K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | FJK | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| March 17, 2010 | K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | FIE | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| February 21, 2008 | K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | FIB | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 4, 2007 | K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | FJK | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| September 7, 2007 | K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | MPB | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| January 12, 2007 | K063721 | NIPRO SAFETOUCH II GAMMA | FIE | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| November 14, 2003 | K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | FOZ | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| June 20, 2001 | K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET | FOZ | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| January 4, 1996 | K955053 | NIPRO SCALP VEIN SET (DISPOSABL PSV SET) | FOZ | Substantially Equivalent | Nissho Corp. | accessdata.fda.gov |
| December 7, 1994 | K944355 | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES | FMF | Substantially Equivalent | Nissho Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Fistula
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Syringe, Piston
- All makers of Catheter, Hemodialysis, Non-Implanted
Updated May 25, 2023. 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.