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HI-TEC MEDICAL GMBH

Germany · Tuttlingen

✓ 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

55listed device types

Class I 23Class II 29Class III 1unclassified 2

plus 62 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

11 including historic records

TWTaiwanTFDA

0valid device licences

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 States62 registration records, 3 510(k), 0 PMA, 43 excluded

Brazil0 confirmed, 13 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: HI MEDICAL CO., LTD. · DENTAL HI TEC · Tosoh Hi-Tec, Inc. · XIAMEN EVERYOUNG OPTICAL HI-TEC CO., LTD. · HI-TEC MEDICAL GMBH · HI TEC IMPLANTS LTD.

FDA 510(k) clearances by year

11994 · K941575

11995 · K930013

11997 · K955477

FDA listed device types

showing 8 of 55

Syringe, Restorative And Impression Material 1Protector, Ostomy 1Accessories, Implant, Dental, Endosseous 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Dressing, Wound, Occlusive 1Sunglasses (Non-Prescription Including Photosensitive) 1Crown, Preformed 1Tape And Bandage, Adhesive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K955477	HI-TEC CO2 INSUFFLATOR TYPE 1300	1997-08-06
US	K930013	CO2 INSUFFLATOR 1100	1995-04-14
US	K941575	SMOOTH FIT	1994-11-17
CA	67679	ASPIRATORS - ENDOSCOPIC IRRIGATION	Class II
CA	67681	INSUFFLATORS/ HYSTEROSCOPIC	Class II
CA	67682	IRRIGATION/ DISTENSION SYSTEMS - ARTHROSCOPIC	Class II

HI-TEC MEDICAL GMBH

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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