Flexicare Medical (Dongguan) Ltd.
Registered establishment in Dongguan, Guangdong, China. 48 device types.
Flexicare Medical (Dongguan) Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Forceps and 46 other device types. Its earliest product listing with the FDA dates from 2006.
48device types registered with the FDA
6recalls
Registration
| Registered name | FLEXICARE MEDICAL (DONGGUAN) LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006061749 |
| FEI number | 3006061749 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 富利凯医疗用品（东莞）有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | No. B-15 XICHENG INDUSTRIAL ZONE |
| Postal code | 523460 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | NasoClear, Nasosafe Pharyngeal Airway | 2006 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Laryseal Plus Laryngeal Mask Airway, Guedel Airway, Laryseal PRO Laryngeal Mask, Williams Airway, Laryseal Laryngeal Mask | 2006 | 84 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | CO2 monitoring, Nasal Cannula, Dualguard, CO2 monitoring Line, Capnocare Monitoring Line With Conical Connector | 2014 | 29 |
| Attachment, Breathing, Positive End Expiratory Pressure | Class 2 | Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP | 2017 | 9 |
| Bag, Reservoir | Class 1 | Venticaire Reservoir Bags | 2006 | 28 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | EZ Flow Catheter Valve – Sterile | 2006 | 52 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | ProVu Video Bronchoscope | 2026 | 21 |
| Cannula, Nasal, Oxygen | Class 1 | Flexicare High Flow Nasal Cannula, Veoflo High Flow Nasal Cannula, Nioflo Oxygen Cannula, Flexicare Nasal Cannula, Veoflo Pro High Flow Nasal Cannula, Dualguard | 2007 | 97 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class 1 | ProVu Vista Tower, ProVu Vista Accessories | 2026 | 34 |
| Catheter And Tip, Suction | Class 2 | Flexicare Closed Suction Catheter | 2021 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | clic Closed Suction Catheter | 2023 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Medisize Breathing Circuit Neonatal, Medisize Breathing Circuit Pediatric, Medisize Breathing Circuit Adult, breathing circuit adult, breathing circuit neonatal, breathing circuit pediatric and 1 more | 2006 | 55 |
| Clamp | Class 1 | ProVu FlexiArm | 2023 | 24 |
| Clamp, Circumcision | Class 2 | Gomco Circumcision Clamp | 2023 | 2 |
| Clip, Nose | Class 1 | Nose Clip | 2023 | 17 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Thermotrach Heat AND Moisture Exchanger, Neonatal HME Connector – Sterile, Flexicare Tracheostomy HME, Kingsystems | 2007 | 29 |
| Connector, Airway (Extension) | Class 1 | Flexicare Connector, Flexible Catheter Mount, Kingsystems, Reusable Angle Connector | 2007 | 20 |
| Device, Fixation, Tracheal Tube | Class 1 | ET Tube Holder | 2019 | 46 |
| Drain, Tee (Water Trap) | Class 1 | Flexicare Water Traps | 2007 | 12 |
| Endoscopic Bite Block | Class 1 | Dualguard, Easyguard | 2014 | 44 |
| Exerciser, Non-Measuring | Class 1 | Mediflo Respiratory Trainer | 2019 | 82 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | Hygrovent, Barr-Vent, Thermoshield HME Filter, 2106570-008 Bacterial Viral Breathing System Filter – NON-Sterile, Hepashield Bacterial Viral Breathing System Filter – NON-Sterile, Hepashield Bacterial Viral Breathing System Filter – Sterile and 2 more | 2010 | 15 |
| Forceps | Class 1 | Flexicare Magill Forceps | 2017 | 99 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class 2 | FL-10000U Respiratory Humidifier, Flexicare Neonatal Heated Wire Breathing Systems, Flexicare Neonatal Ventimyst Heated Wire Breathing Systems, Flexicare Heated Wire Breathing Systems, Flexicare Adult Ventimyst Heated Wire Breathing Systems | 2015 | 4 |
| Holding Chambers, Direct Patient Interface | Class 2 | InspiraChamber, VentiChamber | 2023 | 3 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | FL-10000U Respiratory Humidifier, Flexicare Neonatal Heated Wire Breathing Systems, Flexicare Neonatal Ventimyst Heated Wire Breathing Systems, Hygrovent Gold Heater and Booster T-Piece, Flexicare Heated Wire Breathing Systems, Flexicare Adult Ventimyst Heated Wire Breathing Systems and 1 more | 2015 | 12 |
| Laryngoscope, Rigid | Class 1 | BritePro Omni, ProVu Video Laryngoscope, BritePro Solo, BriteBlade Pro, ProVu Lite | 2006 | 44 |
| Mask, Gas, Anesthetic | Class 1 | Flexicare Silicone Anaesthetic Face Masks, Flexicare Anaesthetic Masks, InspiraMask, SootherMask | 2007 | 71 |
| Mask, Oxygen | Class 1 | Flexicare Aerosol Masks, Flexicare Cpap Mask Head Strap, Flexicare First AID Mask, Venticaire Medium Concentration Masks | 2006 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venticaire Venturi Mask, Ventimask Venturi Masks, Venticaire | 2006 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Venticaire NON-Rebreathing Mask | 2006 | 72 |
| Mask, Scavenging | Class 1 | Single USE Nasal Hood (Scented & Unscented), Reusable Nasal Hood (Unscented) | 2013 | 158 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class 2 | Single Use Manometer for Flexicare Single Use Resuscitator Bag | 2022 | 7 |
| Mouthpiece, Breathing | Class 1 | Flexicare Mouthpiece, ONE WAY Valve EXP(200), ONE WAY Valve:exp (5X20), ONE WAY Valve Insp (200), ONE WAY Valve:insp (5X20), ONE WAY Valve Insp (500) | 2007 | 67 |
| Nebulizer (Direct Patient Interface) | Class 2 | Maxineb DUO Nebulizer | 2019 | 42 |
| Screw, Oral | Class 1 | Jaw Opener | 2019 | 2 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Veoflo Tracheostomy Interface, Flexicare Breathing Circuit Tubing, Venticaire Circuits | 2006 | 33 |
| Stand, Infusion | Class 1 | ProVu Pole Stand, ProVu Table Stand | 2019 | 75 |
| Strap, Head, Gas Mask | Class 1 | Flexicare Cpap Mask Head Strap | 2015 | 29 |
| Stylet, Tracheal Tube | Class 1 | Flexicare Stylets – Various Sizes, Flexicare Bougies – Various Sizes, ProVu Endotracheal Tube with Video Stylet | 2009 | 34 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | Leg Bag Holder Strap | 2006 | 13 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | EZ-Flow catheter valve | 2006 | 23 |
| Tube, Tracheal (W/Wo Connector) | Class 2 | Flexicare Endotracheal Tubes, VentiSeal Endotracheal Tubes, ProVu Endotracheal Tube with Video Stylet | 2009 | 9 |
| Tubing, Noninvasive | Class 2 | Flexicare Suction Tubes – Sterile, Flexicare Suction Tubing, Continuous Coil – NON Sterile | 2015 | 33 |
| Tubing, Pressure And Accessories | Class 1 | Flexicare APL Valve, Flexicare Pressure Relief Valve, Flexicare Oxygen Tubing | 2007 | 45 |
| Unit, Filter, Membrane | Class 1 | Disc filter | 2013 | 17 |
| Urinometer, Mechanical | Class 2 | Urimeter | 2024 | 1 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | NeoPIP Infant Resuscitation Unit, Flexicare Single USE Resuscitator BAG – Pediatric, Flexicare Single USE Resuscitator BAG – Adult, Flexicare Single USE Resuscitator BAG – Infant | 2017 | 8 |
Recalls
6 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Class I | Nonconforming Material/Component | Laryngoscope handles may not illuminate as intended. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 600 |
| Main products | Laryngeal mask airways, Breathing systems, Nebulizers, Nasal cannulas, Anesthesia circuits |
| Certifications | FDA |
| Export markets | Global |
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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