GaleMed (Xiamen) Co., Ltd.
Manufacturer and brand owner in Xiamen, Fujian, China. 33 device types, 29 products catalogued.
GaleMed (Xiamen) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clip, Nose, Mask, Oxygen and 31 other device types. 29 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2004.
33device types registered with the FDA
29products catalogued under its own name
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006783791 |
| FEI number | 3006783791 |
| DUNS | 527333326 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road |
| Postal code | 361026 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Berman Airway, Guedel Airway 8cm, Green, Guedel Airway 9cm, Yellow, Berman Airway 9cm, Color Coded Airways, Berman 7CM Drawing REV1 and 3 more | 2007 | 84 |
| Attachment, Breathing, Positive End Expiratory Pressure | Class 2 | VentStar Resuscitaire CEU, Single Limb Circuit for Pneupac Ventilators, Dual Limb Circuit for Pneupac Ventilators, Single Limb Circuit for Pneupac® paraPAC plusTM Ventilator with 0-20 cmH2O PEEP Valve and Internal Pressure Monitoring, Single Limb Circuit for Pneupac® DEMAND type Ventilators, Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve and Pressure Monitoring Line with In-Line Filt and 19 more | 2008 | 9 |
| Bag, Reservoir | Class 1 | Silicone Breathing Bag, 1L, Latex-Free Breathing Bag 1L, Latex-Free Breathing Bag 3L, Silicone Breathing Bag, 3L, Silicone Breathing Bag, 0.5L, Latex-Free Breathing Bag 2L and 13 more | 2013 | 28 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal oxygen cannula, Flow Indicator w/tubing, 160cm, C22 Star Lumen Tubing, 1000cm, Adult Nasal Cannula With Tubing, Oxi.Plus Nasal Cannula Set, #2, Adult Nasal Cannula W/O Tubing and 21 more | 2011 | 97 |
| Cardiopulmonary Resuscitation Aid Kit | Class 2 | 2013 | 3 | |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Swivel Anesthesia Circuit, Adult, Coaxial Circuit, Adult, 1.5m, Coaxial Circuit, Adult, 1.8m, Disposable anesthesia circuit 1.5m (Adult, latex-free breathing bag 3L), CV-3 Manifold, L22M, Coaxial Circuit, Adult, 2.5m and 47 more | 2007 | 55 |
| Clip, Nose | Class 1 | Clip, Nose | 2011 | 17 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | HME | 2012 | 29 |
| Connector, Airway (Extension) | Class 1 | Valves Aerosol Tee Adaptor, T Connector, 10F, 4.3F, 10/7.6mm, Straight Connector 22/15mm, 15M, Luer, Disposable elbow connector, Reusable wye connector, Disposable swivel wye connector and 54 more | 2007 | 20 |
| Drain, Tee (Water Trap) | Class 1 | water trap, Reusable water trap, Water trap set | 2013 | 12 |
| Exerciser, Non-Measuring | Class 1 | EMST150 expiratory muscle device, Bravo Trainer, Blue | 2023 | 82 |
| Exerciser, Non-Measuring For Stroke Rehabilitation | Class 1 | EMST75 Lite Respiratory Trainer | 2023 | 10 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | AF Viral/Bacterial Filter, Hydrophobic Filter, 7.6M w/Luer, Auto Chamber, Infant, Filter 22F/15M w/Luer, Filter, 30F, 30M, Filter, 22F/15M, 22/15mm and 3 more | 2012 | 15 |
| Gas, Collecting Vessel | Class 1 | Galemed Gas sampling line, Gas Sampling Line, 300cm, R1 Connector | 2015 | 2 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | Humidification Chamber Disposable, Disp. humi.chamber f.F&P MR850, Flowrest | 2013 | 12 |
| Mask, Gas, Anesthetic | Class 1 | Aircushion mask, Aircushion mask with hook ring, Sure Seal Anesthetic Mask, Silicone mask, Reusable mask, Economy reusable mask and 56 more | 2004 | 71 |
| Mask, Oxygen | Class 1 | AM-2 Aerosol Mask, Child, Nasal Cpap Mask, Silicone mask, size 1, infant large, Economy reusable mask, #3, child large, Aircushion mask, Size 5, Adult Large, Economy reusable mask, #5, adult large and 33 more | 2007 | 126 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class 2 | Venti.Plus Disposable Pressure Manometer, Disposable Pressure Manometer | 2010 | 7 |
| Mouthpiece, Breathing | Class 1 | Mouth Piece, 13M | 2025 | 67 |
| Nebulizer (Direct Patient Interface) | Class 2 | GaleMed Large Volume Nebulizer, Neb-Easy Nebulizer, Galemed Nebulizer SET, Galemed Large Volume, RF1 Nebulizer w/Valve T Kit, 22F, 22M, RF1 Nebulizer w/Valve T Kit, 22M, 22M and 5 more | 2007 | 42 |
| Regulator, Pressure, Gas Cylinder | Class 1 | Disposable Tail-End Valve | 2015 | 27 |
| Resuscitator, Manual, Non Self-Inflating | Class 2 | Venti.PIus Hyperinflation Bag System with Pressure Manometer | 2013 | 2 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Hydrophobic filter for pressure tubing line, Silicone breathing hose, adult, 0.45m, Gas Sampling Line, Neonate 2.5 m, Gas Sampling Line, Adult 2.5 m, EVA SB Hose, 22F, 120cm, Silicone breathing hose and 20 more | 2007 | 33 |
| Spirometer, Monitoring (W/Wo Alarm) | Class 2 | Exhalometer | 2012 | 5 |
| Strap, Head, Gas Mask | Class 1 | Silicone headband, Headgear for CPAP, L, Black, Headgear for CPAP Mask, L, Silicone, Headgear for mask, L, Rubber | 2014 | 29 |
| Sv70 Ventilator | Class 2 | Nihon Kohden Exhalation Port | 2024 | 4 |
| Transducer, Gas Pressure | Class 1 | 2015 | 1 | |
| Tubing, Pressure And Accessories | Class 1 | Fits-all Oxygen Tubing Connector, Universal connector, Swivel Oxygen Tubing Connector, Male/Male, Swivel Oxygen Tubing Connector, Male/Female, C22 Star Lumen Tubing, 200cm, 6M, C22 Tubing, 200cm, 6/4mm and 2 more | 2016 | 45 |
| Valve, Non-Rebreathing | Class 2 | PocketPak Mouth-to-Mask Resuscitator | 2013 | 19 |
| Ventilator, Continuous, Facility Use | Class 2 | VentStar Oxylog 1000 180, Utopia NE Full face mask, Hybrid NE Interface, VentStar Oxylog 3000F (P) 190 | 2013 | 8 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | 1ST Response Infant Manual Resuscitator, 1ST Response Pediatric Manual Resuscitator, Ventilator, emergency, manual(resus, 1″ Response Manual Resuscitator, Adult, Lifesaver Single Patient USE Manual Resuscitator, Hudson RCI Lifesaver Single Patient USE Manual Resuscitator and 18 more | 2008 | 8 |
| Ventilator, Emergency, Powered (Resuscitator) | Class 2 | Single Limb Circuit for Pneupac Ventilators, Dual Limb Circuit for Pneupac Ventilators, Single Limb Circuit for Pneupac® paraPAC plusTM Ventilator with 0-20 cmH2O PEEP Valve and Internal Pressure Monitoring, Single Limb Circuit for Pneupac® DEMAND type Ventilators, Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve and Pressure Monitoring Line with In-Line Filt, Single Limb Circuit for Pneupac® paraPAC plusTM Ventilators with Internal Pressure Monitoring Line with In-Line Filter and 2 more | 2015 | 4 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | Hybrid Complete System, Hybrid AV Interface, Sylent NE, Sylent, Bravo II, Bravo and 11 more | 2007 | 18 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Lifesaver | BTM | 16 |
| Mindray | BYG | 12 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 10 |
| Mindray | BTC | 9 |
| GaleMed | BZA | 8 |
| Mindray | BZO | 6 |
| Ambu | BSJ | 6 |
| Connector, Airway (Extension) | BZA | 5 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 5 |
| Venti.Plus | NHK | 4 |
| Nebulizer (Direct Patient Interface) | CAF | 4 |
| Mindray | CAI | 3 |
| Mindray | BZA | 3 |
| Ventilator, Non-Continuous (Respirator) | BZD | 3 |
| Airway, Oropharyngeal, Anesthesiology | CAE | 3 |
| GaleMed | BTM | 3 |
| mindray | OFP | 2 |
| Sil-Flex | BZO | 1 |
| GaleMed | JAY | 1 |
| Cannula, Nasal, Oxygen | CAT | 1 |
| GaleMed | CAP | 1 |
| Mouthpiece, Breathing | BYP | 1 |
| Tubing, Pressure And Accessories | BYX | 1 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 1 |
| GaleMed | BXO | 1 |
| Softip-1 Nasal Cannula, Child | CAT | 1 |
| GaleMed | BYE | 1 |
| Sil-Flex | BSJ | 1 |
| Livesaver | BTM | 1 |
Clearances
No clearance names GaleMed (Xiamen) Co., Ltd. as applicant. 8 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K133957 | 2014-04-14 | BYE | Traditional | Galemed Corp. |
| K102377 | 2010-11-18 | CAP | Traditional | A Plus International, Inc |
| K092687 | 2009-11-23 | NHK | Traditional | A Plus International, Inc |
| K082092 | 2008-10-15 | BTM | Traditional | Galemed Corp. |
| K072755 | 2007-11-16 | BZD | Traditional | Galemed Corp. |
| K021742 | 2002-10-25 | CAF | Traditional | Galemed Corp. |
| K951043 | 1995-06-07 | BSJ | Traditional | Promedic, Inc. |
| K895589 | 1990-03-30 | BTM | Traditional | Hudson Oxygen Therapy Sales Co. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1986 |
|---|---|
| Employees | 650+ |
| Main products | Airway management products, Breathing circuits, Humidification systems, Manual resuscitators, Patient interface solutions |
| Certifications | ISO 9001, EN46001, CE, ISO 14001:2015, ISO 13485, MDSAP, ISCC PLUS |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
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