Data / Medical devices / Indonesia / PT. Nipro Indonesia Jaya
PT. Nipro Indonesia Jaya: FDA-registered device maker in Karawang Jawa Barat, Indonesia, 4 510(k) clearances
PT. Nipro Indonesia Jaya is registered with the FDA (registration 3010377171) in Karawang Jawa Barat, Indonesia. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 9, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010377171
- Address
- Kawasan Industri Suryacipta, Jl. Surya Utama Kav. I 22B, 23 & 24 Desa Kutamekar, Kec. Ciampel, Karawang Jawa Barat, Indonesia, 41361
- Owner or operator
- NIPRO CORPORATION (8030375)
- Roles
- Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2026
- Brand names listed
- Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set, Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set, Nipro Syringe, Nipro blood tubing set, Surdial DX Hemodialysis System and Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 9, 2019 | K191359 | Nipro Syringe | FMF | 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 |
| September 28, 2012 | K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | FJK | 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 |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
Updated October 9, 2019. 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.