Data / Medical devices / United States / Intelimas Corporation
Intelimas Corporation: FDA-registered device maker in Londonderry, NH, United States, 13 510(k) clearances
Intelimas Corporation is registered with the FDA (registration 3023228837) in Londonderry, NH, United States. It lists 21 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023228837
- Address
- 20 North Weymouth Avenue, Londonderry, NH, United States, 03053
- Owner or operator
- INTELIMAS CORPORATION (10085609)
- Roles
- Repackager or relabeler
- First device listed
- August 2, 2022
- Registered through
- 2026
- Brand names listed
- ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C, Accessories, pump, infusion, Applicator, absorbent tipped, sterile, CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE, Drape, surgical, EYQ / GARMENT, PROTECTIVE, FOR INCONTINENCE, FMI / Needle, hypodermic, single lumen FMF / Syringe, piston MEG / SYRINGE, ANTISTICK, FPA / Set, administration, intravascular 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 |
|---|---|---|---|---|---|---|
| March 1, 2022 | K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | MEG | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| December 2, 2021 | K212578 | Nitrile disposable examination gloves | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| March 26, 2021 | K201634 | RG 3ml Medication Cartridge | MRZ | Substantially Equivalent | Chengdu Shifeng Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 12, 2020 | K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | PNR | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| May 31, 2017 | K162601 | Infusion Set for Single Use | FPA | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| August 26, 2016 | K152197 | Skypro, SP01 Mask | FXX | Substantially Equivalent | Skypro Medical Supplies Company | accessdata.fda.gov |
| September 24, 2015 | K151151 | U & U Intravascular Administration Set | FPA | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| December 12, 2012 | K121152 | SURGICAL GOWN, SMS | FYA | Substantially Equivalent | Jiangsu Guangda Medical Material, Co., Ltd. | accessdata.fda.gov |
| September 29, 2011 | K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | KKX | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
| August 2, 2011 | K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE | FYA | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
| July 12, 2010 | K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | JKA | Substantially Equivalent | Guangzhou Improve Medical Instruments Co., Ltd. | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| August 17, 2000 | K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | KKX | Substantially Equivalent | China Nantong Guangda Textile Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Set, Administration, Intravascular
- All makers of Drape, Surgical, Antimicrobial
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Gown, Surgical
Updated March 1, 2022. 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.