HomeHong KongProlinair Asia Limited

Prolinair Asia Limited

Hong Kong · Ha Tsuen Yuen Long N.T
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
19listed device types
Class I 2Class II 16Class III 0unclassified 1
plus 100 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States100 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: Prolinair Asia Limited

Company information

Country
Hong Kong
City
Ha Tsuen Yuen Long N.T

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 19
Electrosurgical, Cutting & Coagulation & Accessories 1System, Image Processing, Radiological 1Bronchoscope (Flexible Or Rigid) 1Laryngoscope, Endoscope 1System, Surgical, Computer Controlled Instrument 1Unit, Cryosurgical, Accessories 1Drape, Surgical, Exempt 1Drape, Surgical, Antimicrobial 1

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