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High Technology Products S.L.U

Spain · Barcelona

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel — 6 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

68listed device types

Class I 31Class II 37Class III 0

plus 71 registration records and 3 510(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

2 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States71 registration records, 3 510(k), 0 PMA, 39 excluded

Brazil2 confirmed, 4 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: High Technology, Inc. · HIGH TECHNOLOGY PRODUCTS, SLU · HIGH TECHNOLOGY PRODUCTS, S.L.U. (COCOON MEDICAL)

FDA 510(k) clearances by year

12019 · K191321

22020 · K201594

FDA listed device types

showing 8 of 68

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 1Electrode, Ion Selective (Non-Specified) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201594	Primelase Excellence	2020-12-17
US	K193367	elysion-pro	2020-03-12
US	K191321	Primelase Excellence	2019-08-02
BR	81504790271	Cool Gel -50	Class I
BR	81504790298	Cool Gel Pad -50	Class I

High Technology Products S.L.U

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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