Data / Medical devices / Malaysia / Sagami Manufacturers Sdn. Bhd. Ipoh Factory
Sagami Manufacturers Sdn. Bhd. Ipoh Factory: FDA-registered device maker in IPOH Perak, Malaysia, 4 510(k) clearances
Sagami Manufacturers Sdn. Bhd. Ipoh Factory is registered with the FDA (registration 3005191252) in IPOH Perak, Malaysia. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005191252
- Address
- 2, Jalan Kilang Tiga Jelapang Light Ind. Estate, IPOH Perak, Malaysia, 30100
- Owner or operator
- SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY (9073700)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- March 24, 2008
- Registered through
- 2026
- Brand names listed
- Kimono, Kimono MicroThin with Aqua Lube, Reality Ultra Lubricated
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 6, 2012 | K113686 | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED | HIS | Substantially Equivalent | Mayer Laboratories, Inc. | accessdata.fda.gov |
| November 8, 1995 | K946374 | KIMONO MICROTHIN | HIS | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| September 22, 1995 | K946376 | MAXX | HIS | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| May 16, 1990 | K897129 | CONDOMS (MULTIPLE BRANDS) | HIS | Substantially Equivalent | Sagami, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 6, 2012. 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.