Data / Medical devices / Japan / Nemoto Kyorindo Co., Ltd.
Nemoto Kyorindo Co., Ltd.: FDA-registered device maker in KAWAGUCHI-SHI Saitama, Japan, 3 510(k) clearances
Nemoto Kyorindo Co., Ltd. is registered with the FDA (registration 9616990) in KAWAGUCHI-SHI Saitama, Japan. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616990
- FEI number
- 3008918179
- Address
- 2-12-23 Aoki Kawaguchi Plant, KAWAGUCHI-SHI Saitama, Japan, 332-0031
- Owner or operator
- NEMOTO KYORINDO CO., LTD. (9043772)
- Roles
- Manufacturer
- First device listed
- October 4, 2012
- Registered through
- 2026
- Brand names listed
- DSA7, Dual Shot Alpha 7, Dual Shot alpha 7, PRESS DUO elite, PRESS DUO elite AG, Rempress, Rempress Angiographic Injection System, alpha 7
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 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 |
|---|---|---|---|---|---|---|
| February 7, 2018 | K173450 | PRESS DUO elite, PRESS DUO elite AG | DXT | Substantially Equivalent | Nemoto Kyorindo Co., Ltd. | accessdata.fda.gov |
| June 30, 2014 | K133189 | DUAL SHOT ALPHA 7 | DXT | Substantially Equivalent | Nemoto Kyorindo Co., Ltd. | accessdata.fda.gov |
| October 29, 2010 | K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | DXT | Substantially Equivalent | Nemoto Kyorindo Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 7, 2018. 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.