Data / Medical devices / Malaysia / The Laryngeal Mask Company (M) SDN. BHD.
The Laryngeal Mask Company (M) SDN. BHD.: FDA-registered device maker in Kulim Kedah, Malaysia, 3 510(k) clearances
The Laryngeal Mask Company (M) SDN. BHD. is registered with the FDA (registration 3009307931) in Kulim Kedah, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 29, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009307931
- Address
- Lot 19, Jalan Hi-Tech 3 Zon Industri Fasa 1, Kulim Hi-Tech Park, Kulim Kedah, Malaysia, 09090
- Owner or operator
- Teleflex (9062981)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- June 18, 2001
- Registered through
- 2026
- Brand names listed
- Airway Lifesaver Kit, Cath-Guide Guedel Airway, Cuff Pilot, Dual Channel Airway, LMA Classic, LMA Classic Excel, LMA Cuff-Deflator, LMA Fastrach and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Manufacturer | accessdata.fda.gov |
| Implantable Transprostatic Tissue Retractor System | PEW | 2 | Contract manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 29, 2025 | K242495 | LMA Fastrach ETT SU | BTR | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| May 8, 2015 | K142103 | CUFF PILOT, SURE SEAL | BSK | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 4, 2000 | K991580 | ILM ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | The Laryngeal Mask Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Implantable Transprostatic Tissue Retractor System
Updated April 29, 2025. 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.