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ACCUTOME INC. ALSO DBA KEELER USA

USA · Malvern

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

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

4active device licences

Class II 2Class III 2

21 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 States0 registration records, 1 510(k), 0 PMA, 3 excluded

Brazil8 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ACCUTOME INC. ALSO DBA KEELER USA · ACCUTOME DBA KEELER USA

Same-named companies — This database also contains companies with near-identical names: ACCUTOME DBA KEELER USA, Accutome, Inc. Doing Business AS Keeler USA. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243227	B-Scan	2025-07-11
BR	80117589169	Accutome UBM Plus Guarded	Class II
BR	80117589170	Paquímetro Portátil PachPen	Class II
BR	80117589171	Accutome A-Scan Plus Connect	Class II
CA	39230	ALGERBRUSH CORNEAL RUST RING REMOVER	Class II
CA	71185	A-SCAN PLUS	Class III
CA	84509	A-SCAN SYNERGY	Class III

ACCUTOME INC. ALSO DBA KEELER USA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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