Data / Medical devices / Malaysia / Elastomade Accessories Sdn Bhd
Elastomade Accessories Sdn Bhd: FDA-registered device maker in Port Klang Selangor, Malaysia, 1 510(k) clearance
Elastomade Accessories Sdn Bhd is registered with the FDA (registration 3005822857) in Port Klang Selangor, Malaysia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 21, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005822857
- Address
- Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara, Port Klang Selangor, Malaysia, 42000
- Owner or operator
- ELASTOMADE ACCESSORIES SDN BHD (9001465)
- Roles
- Manufacturer
- First device listed
- April 7, 2008
- Registered through
- 2026
- Brand names listed
- Dental Dam, Exercise band/Exercise resistance band, Royal Shield Latex Free Dental Dam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | 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 |
|---|---|---|---|---|---|---|
| September 21, 1994 | K942992 | ROYAL SHIELD RUBBER DAMS | EIE | Substantially Equivalent | Elastomade Accessories Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated September 21, 1994. 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.