Data / Medical devices / India / Magnum Health And Safety Pvt Ltd
Magnum Health And Safety Pvt Ltd: FDA-registered device maker in TALUKA - VASAI PALGHAR Maharashtra, India, 1 510(k) clearance
Magnum Health And Safety Pvt Ltd is registered with the FDA (registration 3018020588) in TALUKA - VASAI PALGHAR Maharashtra, India. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3018020588
- Address
- Plot No.19, Near Vasai Frozen Food Company, Kaman Bhiwandi Road Village - Poman, TALUKA - VASAI PALGHAR Maharashtra, India, 401208
- Owner or operator
- MAGNUM HEALTH AND SAFETY PVT LTD (10081244)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 29, 2021
- Registered through
- 2026
- Brand names listed
- 3Ply Surgical Mask - Viroguard (Ear loop/Tie), Bouffant Cap, Disposable Surgical Face Mask (2200,2300,1200,1300), Medline Surgical Face Mask and Medline Procedural Face Mask, Shoe Cover Non-Woven / Shoe Cover PE, Surgeon Cap, Surgical N95 Respirator, Model Number : MH 3D PLUS-S, Surgical N95 Respirator, Model Number : MH CUP-S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 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 |
|---|---|---|---|---|---|---|
| June 28, 2022 | K220670 | Magnum | FXX | Substantially Equivalent | Magnum Health and Safety Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Respirator, Surgical
- All makers of Cover, Shoe, Operating-Room
- All makers of Cap, Surgical
Updated June 28, 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.