Consulting Wallah › Device Explorer › Gloves & PPE › Reinforced laryngeal mask airway, single-use
Device Explorer · FDA GUDID · GMDN 47803

Reinforced laryngeal mask airway, single-use

A curved armoured tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is

US‑registered devices53in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile74%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Tianjin Medis Medical Device Co.,Ltd.1630%
Jiangxi Yiles Medical Co., Ltd1426%
Dynarex Corporation1426%
Hangzhou Formed Medical Devices Co.Ltd.815%
Microtek Medical Llc12%

Top labelers

CompanyDevicesShare
Tianjin Medis Medical Device Co.,Ltd.1630%
Jiangxi Yiles Medical Co., Ltd1426%
Dynarex Corporation1426%
Hangzhou Formed Medical Devices Co.Ltd.815%
Microtek Medical Llc12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ultra FlexUltra Flex TCLaryngeal Mask, Silicone Reinforced, Size 6.0Laryngeal Mask, Silicone Reinforced, Size 5.0Laryngeal Mask, Silicone Reinforced, Size 4.0Laryngeal Mask, Silicone Reinforced, Size 3.0Laryngeal Mask, Silicone Reinforced, Size 2.5Laryngeal Mask, Silicone Reinforced, Size 2.0Laryngeal Mask, Silicone Reinforced, Size 1.5Laryngeal Mask, Silicone Reinforced, Size 1.0INTERSURGICALResp-O2 Laryngeal Mask Airways Silicone, Non-ReiResp-O2 Laryngeal Mask Airways Silicone, Non-ReiResp-O2 Laryngeal Mask Airways Silicone, Non-ReiResp-O2 Laryngeal Mask Airways Silicone, Non-ReiResp-O2 Laryngeal Mask Airways Silicone, Non-Rei

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
CAEAirway, Oropharyngeal, Anesthesiology59
KKXDrape, surgical1

GMDN & GCC registration

  • GMDN code 47803 · non‑implantable
  • Single‑use 100% · sterile 74% · Rx‑only 26% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many reinforced laryngeal mask airway, single-use products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reinforced laryngeal mask airway, single-use", from 5 companies. The largest labeler is Tianjin Medis Medical Device Co.,Ltd. with 30% of records.

Which FDA product codes apply?

CAE (Airway, Oropharyngeal, Anesthesiology), KKX (Drape, surgical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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