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Home›United Kingdom of Great Britain and Northern Ireland›Medical House (Asi) Limited

Medical House (Asi) Limited

United Kingdom of Great Britain and Northern Ireland · Sheffield
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
8listed device types
Class I 4Class II 3Class III 0unclassified 1
plus 2 registration records and 6 510(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
2 including historic records
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 States2 registration records, 6 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: ASI MEDICAL, INC.
Same-named companies — This database also contains companies with near-identical names: ASI MEDICAL, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Sheffield

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 510(k) clearances by year

11994 · K932873
21998 · K974488
12008 · K073476
12012 · K110481
12013 · K123139

FDA listed device types

Handpiece, Belt And/Or Gear Driven, Dental 1Handpiece, Direct Drive, Ac-Powered 1Plugger, Root Canal, Endodontic 1Unit, Operative Dental 1Scaler, Ultrasonic 1Drill, Bone, Powered 1Activator, Ultraviolet, For Polymerization 1Locator, Root Apex 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123139ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES2013-03-28
USK110481TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE2012-04-05
USK073476COMPACT AUTO-SAFETY INJECTOR (CASI)2008-03-07

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