HomeSri LankaFlexicare Lanka (Pvt) Ltd

Flexicare Lanka (Pvt) Ltd

Sri Lanka · Bandaragama Western
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
17listed device types
Class I 12Class II 5Class III 0
plus 22 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 2Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States22 registration records, 0 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Flexicare Lanka (Pvt) Ltd

Company information

Country
Sri Lanka
City
Bandaragama Western

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 17
Filter, Bacterial, Breathing-Circuit 1Meter, Peak Flow, Spirometry 1Attachment, Breathing, Positive End Expiratory Pressure 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Tubing, Noninvasive 1Mask, Oxygen, Low Concentration, Venturi 1Mouthpiece, Breathing 1Laryngoscope, Rigid 1

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