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High Technology, Inc.

USA · North Attleboro

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Russia — 5 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

81listed device types

Class I 43Class II 38Class III 0

plus 87 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

12active registrations

Class 1 1Class 2a 11

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 States87 registration records, 6 510(k), 0 PMA, 33 excluded

Brazil2 confirmed, 4 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: High Technology, Inc. · GuoLong (Shenzhen) High Technology Co., Ltd · XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO.,LTD. · HIGH SPOT HEALTH TECHNOLOGY CO., LTD. · HIGH TECHNOLOGY PRODUCTS, S.L.U. (COCOON MEDICAL) · XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO., LTD.

FDA 510(k) clearances by year

11987 · K873580

12019 · K191321

22020 · K201594

12022 · K212713

12026 · K260529

FDA listed device types

showing 8 of 81

Diluent, Blood Cell 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Acid, Lactic, Enzymatic Method 1Ferrozine (Colorimetric) Iron Binding Capacity 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Microscope, Inverted Stage, Tissue Culture 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Splint, Hand, And Components 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260529	Air Compression Massager (HY-1165)	2026-07-27
US	K212713	Air compression leg massager HY-1117A	2022-01-18
US	K201594	Primelase Excellence	2020-12-17
BR	81504790271	Cool Gel -50	Class I
BR	81504790298	Cool Gel Pad -50	Class I

High Technology, 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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