LMA Airway Management

LMA® Unique™ (Silicone Cuff) Airway with Cuff Pilot(TM) Technology Size 2.5

Registry build 21.09.26
84manufacturers in China registered for this device type
444catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Zhejiang (30), Guangdong (18), Jiangsu (12). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAE
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12

Showing 12 of 84. All 84 manufacturers in China registered for Airway, Oropharyngeal, Anesthesiology

Record

Regulatory record for LMA Airway Management
Listed by Teleflex Medical LLC, United States
FDA product code CAE
Device type Airway, Oropharyngeal, Anesthesiology
Device class Class 1
Regulation 21 CFR 868.5110
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-04-30
Record revised 2025-09-18 (version 6)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Special storage condition: Dark cool environment avoid direct sunlight
Packaging Carton of 5, box of 10, pallet of 36, bag of 10, pallet of 20, pallet of 27
Distribution end date 2025-07-31
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for LMA Airway Management
Catalogue number Size Per pack Status
IPN929453 Size 4 In distribution
IPN916589 In distribution
IPN915908 Size 1.5 In distribution
IPN901752 Size 4 In distribution
IPN046932 Size 3 In distribution
IPN914126 Size 2 In distribution
IPN922049 Size 1 In distribution
IPN900838 Size 5 In distribution
IPN914131 Size 6 In distribution
IPN916590 In distribution
IPN922880 Size 4 In distribution
IPN914125 Size 1.5 In distribution
IPN929449 Size 1.5 In distribution
IPN929396 Size 2 In distribution
IPN916600 In distribution
IPN929399 Size 4 In distribution
IPN900612 Size 3 In distribution
IPN902073 Size 4 In distribution
IPN922805 In distribution
IPN924055 Size 2.5 In distribution
IPN923487 Size 4 In distribution
IPN922889 Size 6 In distribution
IPN056620 Size 2 In distribution
IPN923211 Size 4 In distribution
IPN924143 Size 1 In distribution
IPN056618 Size 1 In distribution
IPN048711 Size 5 In distribution
IPN048714 Size 3 In distribution
IPN914302 20 In distribution
IPN048715 Size 4 In distribution
IPN922895 Size 2 In distribution
IPN922772 Size 4 In distribution
IPN048713 Size 2.5 In distribution
IPN056590 Size 2 In distribution
IPN922815 Size 5 In distribution
IPN923656 Size 4 In distribution
IPN039838 Size 4 In distribution
IPN041155 Size 6 In distribution
IPN922064 Size 5 In distribution
IPN916565 Size 3 In distribution
IPN923208 Size 4 In distribution
IPN924150 Size 6 In distribution
IPN039833 Size 1 In distribution
IPN923662 Size 5 In distribution
IPN916598 In distribution
IPN914304 20 In distribution
IPN924052 Size 4 In distribution
IPN041151 Size 2.5 In distribution
IPN039837 Size 3 In distribution
IPN924144 Size 1.5 In distribution
IPN041137 Size 4 In distribution
IPN056621 Size 2.5 In distribution
IPN916592 In distribution
IPN922881 Size 5 In distribution
IPN039748 Size 4 In distribution
IPN922816 Size 3 In distribution
IPN922892 Size 5 In distribution
IPN922062 Size 3 In distribution
IPN914124 Size 1 In distribution
IPN041125 Size 5 In distribution
IPN901790 Size 1.5 In distribution
IPN041154 Size 5 In distribution
IPN927071 Size 4 In distribution
IPN047070 Size 3 In distribution
IPN048773 In distribution
IPN913663 In distribution
IPN922800 Size 3 In distribution
IPN915413 Size 3 In distribution
IPN922894 Size 1.5 In distribution
IPN922803 In distribution
IPN901666 Size 5 In distribution
IPN922797 In distribution
IPN900617 Size 2 In distribution
IPN041114 In distribution
IPN914284 20 In distribution
IPN901827 Size 4 In distribution
IPN901740 Size 2 In distribution
IPN916597 In distribution
IPN915917 Size 2 In distribution
IPN915410 Size 1.5 In distribution
IPN915414 Size 4 In distribution
IPN922799 In distribution
IPN913664 In distribution
IPN901664 Size 3 – 4 In distribution
IPN915919 Size 3 In distribution
IPN900616 Size 1.5 In distribution
IPN916602 In distribution
IPN929400 Size 5 In distribution
IPN900608 Size 1 In distribution
IPN047900 Size 3 In distribution
IPN915916 Size 1.5 In distribution
IPN041123 Size 3 In distribution
IPN900618 Size 2.5 In distribution
105300-000050 SIZE 5 In distribution
IPN924137 Size 2 In distribution
IPN929454 Size 5 In distribution
IPN039836 Size 2.5 In distribution
IPN922810 Size 3 In distribution
IPN914129 Size 4 In distribution
IPN922811 Size 4 In distribution
IPN041144 In distribution
IPN923478 Size 3 In distribution
IPN041143 In distribution
IPN913662 In distribution
IPN047903 Size 3 In distribution
IPN901742 Size 2.5 In distribution
IPN922780 Size 4 In distribution
IPN922052 In distribution
IPN041152 Size 3 In distribution
IPN915907 Size 1 In distribution
IPN900620 Size 4 In distribution
IPN915909 Size 2 In distribution
IPN915915 Size 1 In distribution
IPN922877 Size 2 In distribution
IPN922779 Size 3 In distribution
IPN923488 Size 5 In distribution
IPN923480 Size 5 In distribution
IPN041148 Size 1 In distribution
IPN923657 Size 5 In distribution
IPN047904 Size 4 In distribution
IPN902063 Size 1.5 In distribution
IPN922053 In distribution
IPN914127 Size 2.5 In distribution
IPN922769 Size 2 In distribution
IPN915921 Size 5 In distribution
IPN914283 20 In distribution
IPN924149 Size 5 In distribution
IPN047590 Size 1 In distribution
IPN048709 Size 3 In distribution
IPN924145 Size 2 In distribution
IPN902070 Size 3 In distribution
IPN917162 Size 2.5 In distribution
IPN917161 Size 2 In distribution
IPN048708 Size 2.5 In distribution
IPN924138 Size 2.5 In distribution
IPN916595 In distribution
IPN922807 Size 1.5 In distribution
IPN056624 Size 5 In distribution
IPN922771 Size 3 In distribution
IPN056593 Size 4 In distribution
IPN923484 Size 2 In distribution
IPN901754 Size 5 In distribution
IPN922770 Size 2.5 In distribution
IPN922794 In distribution
IPN041107 Size 3 In distribution
IPN924051 Size 3 In distribution
IPN039840 Size 6 In distribution
IPN039834 Size 1.5 In distribution
IPN901826 Size 3 In distribution
IPN924136 Size 1.5 In distribution
IPN039747 In distribution
IPN929450 Size 2 In distribution
IPN056619 Size 1.5 In distribution
IPN922057 In distribution
IPN922789 In distribution
IPN922796 In distribution
IPN915922 Size 6 In distribution
IPN916593 In distribution
IPN917160 Size 1.5 In distribution
IPN915407 Size 4 In distribution
IPN917181 In distribution
IPN056589 Size 1.5 In distribution
IPN923207 Size 3 In distribution
IPN923660 Size 3 In distribution
IPN922808 Size 2 In distribution
IPN915920 Size 4 In distribution
IPN901828 Size 5 In distribution
IPN922893 Size 1 In distribution
IPN922900 Size 4 In distribution
IPN900614 Size 5 In distribution
IPN901796 Size 3 In distribution
IPN922899 Size 3 In distribution
IPN922790 In distribution
IPN901801 Size 4 In distribution
IPN039839 Size 5 In distribution
IPN923474 Size 1 In distribution
IPN922050 Size 1.5 In distribution
IPN048783 In distribution
IPN915411 Size 2 In distribution
IPN901799 Size 4 In distribution
IPN922774 Size 6 In distribution
IPN917182 In distribution
IPN922058 Size 4 In distribution
IPN041136 Size 3 In distribution
IPN922778 Size 2.5 In distribution
IPN922885 Size 2.5 In distribution
IPN929448 Size 1 In distribution
IPN922063 Size 4 In distribution
IPN924147 Size 3 In distribution
IPN924054 Size 2 In distribution
IPN924058 Size 5 In distribution
IPN922054 In distribution
IPN041115 In distribution
IPN047595 Size 4 In distribution
IPN923479 Size 4 In distribution
IPN916619 Size 1 In distribution
IPN922814 Size 4 In distribution
IPN902061 Size 1 In distribution
IPN047593 In distribution
IPN901859 Size 1 In distribution
IPN922061 Size 2.5 In distribution
IPN924146 Size 2.5 In distribution
IPN915914 Size 6 In distribution
IPN041108 Size 4 In distribution
IPN917159 Size 1 In distribution
IPN915415 Size 5 In distribution
IPN915412 In distribution
IPN048778 In distribution
IPN902065 Size 2 In distribution
IPN922876 Size 5 In distribution
IPN900836 Size 3 In distribution
IPN922879 Size 3 In distribution
IPN047897 Size 3 In distribution
IPN916561 Size 4 In distribution
IPN924141 Size 5 In distribution
IPN923210 Size 3 In distribution
IPN923475 Size 1.5 In distribution
IPN923658 Size 2 In distribution
IPN048781 In distribution
IPN913660 In distribution
IPN916620 In distribution
IPN041146 In distribution
IPN041133 Size 1.5 In distribution
IPN915918 Size 2.5 In distribution
IPN929452 Size 3 In distribution
IPN929398 Size 3 In distribution
IPN056731 In distribution
IPN039749 Size 5 In distribution
IPN929397 Size 2.5 In distribution
IPN900621 Size 5 In distribution
IPN916563 Size 2 In distribution
IPN041135 Size 2.5 In distribution
IPN048780 In distribution
IPN041116 In distribution
IPN922806 Size 1 In distribution
IPN922874 Size 3 In distribution
IPN902076 Size 5 In distribution
IPN916560 Size 3 In distribution
IPN916624 In distribution
IPN916599 In distribution
IPN915395 In distribution
IPN923485 Size 2.5 In distribution
IPN046945 In distribution
IPN047591 Size 1.5 In distribution
IPN924056 Size 3 In distribution
IPN922776 Size 1.5 In distribution
IPN900613 Size 4 In distribution
IPN922875 Size 4 In distribution
105300-000030 SIZE 3 In distribution
IPN922775 Size 1 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rusch Teleflex Medical LLC 129
SourceMark Sourcemark, LLC. 94
Curaplex Bound Tree Medical, LLC 86
Hudson RCI Teleflex Medical LLC 83
SunMed SunMed Group Holdings, LLC 66
Medline Medline Industries, Inc. 59
LMA Teleflex Medical LLC 50
MediChoice Owens & Minor Distribution, Inc. 33
ADC® American Diagnostic Corp. 32
Air-Q3® Airlife, Inc. 32
Compower Xiamen Compower Medical Tech. Co., Ltd. 29
Airway, Oropharyngeal, Anesthesiology VBM Medizintechnik Gmbh 26

Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2015-01-13 Class II Other The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff). 2640 units 2016-09-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer