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H&H Instruments

USA · St Augustine

✓ 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

96listed device types

Class I 94Class II 2Class III 0

plus 119 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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

1 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 States119 registration records, 6 510(k), 0 PMA, 666 excluded

Brazil7 confirmed, 275 excluded

Saudi Arabia0 confirmed, 109 excluded

Canada0 confirmed, 91 excluded

Manufacturer names merged into this page: M.J. INSTRUMENTS COMPANY (PVT) LTD. · G.M. INSTRUMENTS LTD. · J & J INSTRUMENTS, LLC · K&S INSTRUMENTS · A & M INSTRUMENTS, INC. · J&J INSTRUMENTS, LLC

Same-named companies — This database also contains companies with near-identical names: A & M INSTRUMENTS, INC., B&K Instruments, Inc., E-Z Instruments Co., J & J INSTRUMENTS, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11977 · K772169

11983 · K833598

11986 · K854396

21992 · K922056

11998 · K972140

FDA listed device types

showing 8 of 96

Knife, Margin Finishing, Operative 1Spreader, Bladder Neck 1Accessories, Implant, Dental, Endosseous 1Clamp, Rubber Dam 1Accessories, Retractor, Dental 1Gag, Mouth 1Chisel, Bone, Surgical 1Dam, Rubber 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K972140	A1 ACOUSTIC RHINOMETER	1998-09-30
US	K922056	HHI ELECTRIC CONSOLE #875-000	1992-09-18
US	K922661	HHI PNEUMATIC ROTARY DRILL	1992-09-18
BR	80801630035	Grampo para Isolamento AllPrime	Class I
BR	80801630038	Moldeira em Aço Inox AllPrime	Class I
BR	80801630019	Tesoura AllPrime	Class I

H&H Instruments

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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