FDA Registration
Active
🇨🇳 China
FLEXICARE MEDICAL (DONGGUAN) LTD.
Reg #: 3006061749
·
FEI: 3006061749
·
Expires 2026
Products
47
Proprietary Names
110
Establishment Types
1
Classifications
47
Registration Details
- Registration Name
- FLEXICARE MEDICAL (DONGGUAN) LTD.
- Registration Number
- 3006061749
- FEI Number
- 3006061749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. B-15 XICHENG INDUSTRIAL ZONE, HENGLI TOWN,
- City
- DONGGUAN CITY Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- FLEXICARE MEDICAL LTD.
- Operator Number
- 8021995
- Address
- CYNON VALLEY BUSINESS PARK
- City
- MOUNTAIN ASH
- State
- Rhondda Cynon Taff
- Postal Code
- CF45 4ER
- Country
- GB
- Correspondent
- Rebecca - Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-10-24 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2019-09-20 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2014-04-17 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2007-01-18 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2007-01-18 |
| Urinometer, Mechanical | EXR | Class 2 | Gastroenterology, Urology | No | 2024-02-19 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2010-05-12 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2023-10-12 |
| Screw, Oral | KBW | Class 1 | Ear, Nose, Throat | No | 2019-09-20 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2007-01-17 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2025-05-21 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2025-05-21 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2006-08-30 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2006-08-30 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2026-01-19 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2026-01-19 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2007-01-17 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2006-08-30 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2017-07-25 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2015-08-12 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-01-17 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2019-02-19 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2019-12-19 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2006-08-30 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2015-01-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-04-21 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2007-01-18 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2013-12-03 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2023-01-19 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2015-08-12 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2022-01-07 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2017-07-25 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2006-08-30 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2007-01-18 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-12-17 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2006-08-30 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2023-12-04 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2026-06-17 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2019-11-19 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2023-10-27 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2006-08-30 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2006-08-30 |
Proprietary Names
ProVu FlexiArm
ET Tube Holder
Nasal Cannula
CO2 monitoring
Flexicare Connector
Flexible Catheter Mount
Kingsystems
FLEXICARE MOUTHPIECE
ONE WAY VALVE EXP(200)
ONE WAY VALVE INSP (500)
ONE WAY VALVE:INSP (5X20)
ONE WAY VALVE INSP (200)
ONE WAY VALVE:EXP (5X20)
Urimeter
Flexicare Breathing Filters
InspiraChamber, VentiChamber
Jaw Opener
FLEXICARE AEROSOL MASKS
FLEXICARE CPAP MASK HEAD STRAP
FLEXICARE FIRST AID MASK
VENTICAIRE MEDIUM CONCENTRATION MASKS
FLEXICARE SILICONE ANAESTHETIC FACE MASKS
FLEXICARE ANAESTHETIC MASKS
SootherMask
InspiraMask
ProVu Endotracheal Tube with Video Stylet
NasoClear
NASOSAFE PHARYNGEAL AIRWAY
EZ FLOW CATHETER VALVE - STERILE
VENTICAIRE NON-REBREATHING MASK
FL-10000U Respiratory Humidifier
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS
FLEXICARE NEONATAL VENTIMYST HEATED WIRE BREATHING SYSTEMS
Flexicare High Flow Nasal Cannula
Veoflo High Flow Nasal Cannula
Nioflo Oxygen Cannula
Flexicare Nasal Cannula
Veoflo Pro High Flow Nasal Cannula
BritePro Omni
ProVu Video Laryngoscope
BriteBlade Pro
BritePro Solo
ProVu Lite
Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP
2106570-008 BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE
HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE
HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - STERILE
Leg Bag Holder Strap
Hygrovent Gold
Disc filter
FLEXICARE PRESSURE RELIEF VALVE
FLEXICARE APL VALVE
FLEXICARE OXYGEN TUBING
MEDIFLO RESPIRATORY TRAINER
Hygrovent Gold Heater and Booster T-Piece
Flexicare Endotracheal Tubes
VentiSeal Endotracheal Tubes
MAXINEB DUO NEBULIZER
VEOFLO TRACHEOSTOMY INTERFACE
Flexicare Breathing Circuit Tubing
VENTICAIRE CIRCUITS
EZ-Flow catheter valve
EASYGUARD
Barr-Vent
Hygrovent
CO2 monitoring Line
CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR
FLEXICARE MAGILL FORCEPS
FLEXICARE WATER TRAPS
THERMOSHIELD HME FILTER
REUSABLE NASAL HOOD (UNSCENTED)
SINGLE USE NASAL HOOD (SCENTED & UNSCENTED)
clic Closed Suction Catheter
FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE
FLEXICARE SUCTION TUBES - STERILE
Single Use Manometer for Flexicare Single Use Resuscitator Bag
NeoPIP Infant Resuscitation Unit
VENTICAIRE VENTURI MASK
VENTIMASK VENTURI MASKS
VENTICAIRE
Flexicare Bougies - Various Sizes
Flexicare Stylets - Various Sizes
FLEXICARE SINGLE USE RESUSCITATOR BAG - INFANT
FLEXICARE SINGLE USE RESUSCITATOR BAG - PEDIATRIC
FLEXICARE SINGLE USE RESUSCITATOR BAG - ADULT
Flexicare Heated Wire Breathing Systems
FLEXICARE ADULT VENTIMYST HEATED WIRE BREATHING SYSTEMS
THERMOTRACH HEAT AND MOISTURE EXCHANGER
NEONATAL HME CONNECTOR - STERILE
FLEXICARE TRACHEOSTOMY HME
Flexicare Closed Suction Catheter
VENTICAIRE RESERVOIR BAGS
Gomco Circumcision Clamp
ProVu Vista Tower, ProVu Vista Accessories
Dualguard
ProVu Pole Stand
ProVu Table Stand
Nose Clip
Medisize Breathing Circuit Adult
breathing circuit pediatric
Medisize Breathing Circuit Pediatric
breathing circuit adult
Medisize Breathing Circuit Neonatal
breathing circuit neonatal
VENTICAIRE BREATHING CIRCUITS
GUEDEL AIRWAY
LARYSEAL PLUS LARYNGEAL MASK AIRWAY
LARYSEAL PRO LARYNGEAL MASK
Williams Airway
LARYSEAL LARYNGEAL MASK
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)