Data / Medical devices / Malaysia / The Female Health Company (M) Sdn Bhd
The Female Health Company (M) Sdn Bhd: FDA-registered device maker in Balakong Selangor, Malaysia, 1 PMA approval
The Female Health Company (M) Sdn Bhd is registered with the FDA (registration 3006633362) in Balakong Selangor, Malaysia. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 10, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006633362
- Address
- No 1a, Jalen CJ 1/4 Kawasan Perindustrian Cheras Jaya, Balakong Selangor, Malaysia, 43200
- Owner or operator
- Clear Future, Inc. (10092736)
- Roles
- Manufacturer
- First device listed
- February 12, 2025
- Registered through
- 2026
- Brand names listed
- FC2 Female Condom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single-Use Internal Condom | MBU | 2 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 10, 2009 | P080002 | FC2 FEMALE CONDOM | MBU | 2 | June 23, 2017 | accessdata.fda.gov |
Updated June 23, 2017. 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.