Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009307931

FEI Number

3009307931

Entity Name

The Laryngeal Mask Company (M) SDN. BHD.

City/State/Country

Kulim Kedah, MY

Establishment Address

Lot 19 , Jalan Hi-Tech 3, Zon Industri Fasa 1, Kulim Hi-Tech Park, Kulim Kedah 09090, MY

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Teleflex (Owner Number: 9062981)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991580

PMA Number

N/A

All Registered Proprietary Names

LMA Fastrach ETT SU LMA ProSeal LMA Fastrach (SU) LMA Unique (Silicone Cuff) LMA Supreme LMA Flexible (SU) Oropharyngeal Guedel Tube Black LMA Cuff-Deflator LMA Unique (Silicone Cuff) Cuff Pilot LMA ProSeal Introducer LMA Unique Evo Cuff Pilot LMA Protector Cuff Pilot LMA Fastrach LMA Flexible LMA ProSeal Cuff Deflator LMA Protector LMA Unique Evo LMA Classic Excel LMA Unique LMA Gastro Cuff Pilot LMA Unique PreCurved LMA Classic LMA Flexible PreCurved LMA Unique PreCurved Cuff Pilot LMA NovaPlus LMA Supreme Plus Pack LMA Flexible PreCurved Cuff Pilot MADgic Airway LMA Fastrach Stabiliser Rod LMA Unique (S) Cuff Pilot LMA Flexible (S) LMA Unique (S) LMA Flexible (S) Cuff Pilot Cath-Guide Guedel Airway Airway Lifesaver Kit Ovassapian Airway Dual Channel Airway UroLift 2 System Cuff Pilot LMA Fastrach ETT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-09-29
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2001-06-18
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	Class 2	876.5530	2023-05-22
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2022-11-02
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-05-20

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Teleflex

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013515223	T.K. India Pvt. Ltd.	Chandigarh, IN
3004365956	Teleflex Medical de Mexico, S. de R.L. de C.V.	NUEVO LAREDO Tamaulipas, MX
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
8040412	Teleflex Medical Sdn. Bhd.	KAMUNTING Perak, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

Similar Registrations

Registration Number	Establishment Name	Location
3021187119	N8 MEDICAL LLC	Dublin, OH, US
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
1420054	LSL HEALTHCARE	Niles, IL, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009307931. Last updated year: 2026. Please use registration number 3009307931 when referencing this establishment in official correspondence.