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Clement Clarke, Inc.

USA · Reynoldsburg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

5listed device types

Class I 2Class II 3Class III 0

plus 8 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 2Class II 7

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

13 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 States8 registration records, 16 510(k), 0 PMA

Brazil9 confirmed, 1 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: CLEMENT CLARKE INTL., LTD. · CLEMENT CLARKE INTERNATIONAL LTD · CLEMENT CLARKE · CLEMENT CLARKE INTERNATIONAL LIMITED

Same-named companies — This database also contains companies with near-identical names: CLEMENT CLARKE INTERNATIONAL LIMITED, CLEMENT CLARKE INTL., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11979

11984

11990

11991

11992

11993

11994

11995

21996

11997

11998

11999

12000

12005

12006

FDA listed device types

Holding Chambers, Direct Patient Interface 1Percussor, Powered-Electric 1Meter, Peak Flow, Spirometry 1Mask, Gas, Anesthetic 1Mouthpiece, Breathing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K053156	MINI-WRIGHT DIGITAL, MODEL 3120001	2006-01-31
US	K042058	ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN	2005-03-23
US	K000368	EYECAP IMAGING SYSTEM	2000-05-04
BR	10332170005	IN CHECK MEDIDOR DE FLUXO INSPIRATORIO	Class II
BR	10332170006	IN CHECK DIAL MEDIDOR DE FLUXO INSPIRATORIO	Class I
BR	10332170007	MINI WRIGHT AIRZONE MEDIDOR DE FLUXO EXPIRATORIO	Class I
SA	ME0000009260SFDAA00001	Disposable Inspiratory One-Way Valve Mouthpieces	—
SA	ME0000009260SFDAA00003	DispoZABLE Spacer	—
CA	34611	VM-1 MINI SPIROMETER	Class II
CA	34614	VM-PLUS RECORDING SPIROMETER	Class II
CA	69881	MINI-WRIGHT DIGITAL	Class II

Clement Clarke, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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