Data / Medical devices / United States / Maude Group, Inc.
Maude Group, Inc.: FDA-registered device maker in New York, NY, United States, 2 510(k) clearances
Maude Group, Inc. is registered with the FDA (registration 3013986076) in New York, NY, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 9, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013986076
- Address
- 161 Water Street #2025, New York, NY, United States, 10038
- Owner or operator
- Maude Group, Inc. (10055751)
- Roles
- Repackager or relabeler
- First device listed
- November 7, 2017
- Registered through
- 2026
- Brand names listed
- Maude Latex Condom, Maude Rise Plus, Rise
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 9, 2001 | K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2001. 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.