FDA Registration
Active
🇱🇰 Sri Lanka
Flexicare Lanka (Pvt) Ltd
Reg #: 3017202422
·
FEI: 3017202422
·
Expires 2026
Products
17
Proprietary Names
65
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- Flexicare Lanka (Pvt) Ltd
- Registration Number
- 3017202422
- FEI Number
- 3017202422
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 382/x, Kumbuka Road, Raigama
- City
- Bandaragama Western
- Country
- LK
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 |
|---|---|---|---|---|---|
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2015-08-12 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2023-07-24 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2010-05-12 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2017-07-25 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2023-10-27 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2007-01-17 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2014-04-17 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2006-08-30 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-01-17 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2007-01-18 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2006-08-30 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2007-01-18 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2006-08-30 |
Proprietary Names
FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE
FLEXICARE SUCTION TUBES - STERILE
MWPFM STD ATS CLAM (TRI-ANIM)
MWPFM STD ATS CLAM
MWPFM STD ATS ATM SINGLE
MW STD ATS (MEDLINE) 12X20 BOX
Flexicare Breathing Filters
Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP
Nose Clip
Flexicare High Flow Nasal Cannula
Veoflo High Flow Nasal Cannula
Nioflo Oxygen Cannula
Flexicare Nasal Cannula
Veoflo Pro High Flow Nasal Cannula
Nasal Cannula
CO2 monitoring
VENTICAIRE RESERVOIR BAGS
IN-CHECK ORAL ATM
VENTICAIRE VENTURI MASK
VENTIMASK VENTURI MASKS
VENTICAIRE
FLEXICARE PRESSURE RELIEF VALVE
FLEXICARE APL VALVE
FLEXICARE OXYGEN TUBING
MWPFM L/R ATS ATM SINGLE
MWPFM AFSLOW RANGE ATS
MW AFS ATS (MEDLINE) 12X30 BOX
Flexicare Connector
Flexible Catheter Mount
Kingsystems
Medisize Breathing Circuit Adult
breathing circuit pediatric
Medisize Breathing Circuit Pediatric
breathing circuit adult
Medisize Breathing Circuit Neonatal
breathing circuit neonatal
VENTICAIRE BREATHING CIRCUITS
BritePro Omni
ProVu Video Laryngoscope
BriteBlade Pro
BritePro Solo
ProVu Lite
THERMOSHIELD HME FILTER
VENTICAIRE NON-REBREATHING MASK
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)
CO2 monitoring Line
CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR
VEOFLO TRACHEOSTOMY INTERFACE
Flexicare Breathing Circuit Tubing
VENTICAIRE CIRCUITS
FLEXICARE AEROSOL MASKS
FLEXICARE CPAP MASK HEAD STRAP
FLEXICARE FIRST AID MASK
VENTICAIRE MEDIUM CONCENTRATION MASKS
Peak Air PF9940 Peak Flow Meter
AIRZONE EVALUPEAK ATS CURAPLEX
AIRZONE WHITE (AIRIAL)
AIRZONE BLUE ATS (US) SINGLE
AIRZONE (MEDLINE) 12X36 BOX
AIRZONE BLUE ATS (EUROPE) CE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)