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Med-Tec,Inc.

USA · Orange City

✓ 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

11510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

SASaudi ArabiaSFDA

57registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

11 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 States0 registration records, 11 510(k), 0 PMA, 44 excluded

Brazil5 confirmed, 16 excluded

Saudi Arabia57 confirmed, 4 excluded

Canada6 confirmed, 7 excluded

Manufacturer names merged into this page: OCEAN PACIFIC MED TEC LTD. · MED TEC INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA - ME · SUZHOU JH MED-TEC CO., LTD · SHENZHEN NEW CONCEPT MED. TEC. CO., LTD. · WULFF MED TEC GMBH · Med-Tec Inc. bda CIVCO Medical Solutions and CIVCO Radiotherapy

Same-named companies — This database also contains companies with near-identical names: MED TEC INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA - ME, OCEAN PACIFIC MED TEC LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132084	PROTURA COUCH SOFTWARE	2013-09-26
US	K122201	PROTURA COUCH SOFTWARE	2012-08-30
US	K034054	PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100	2004-02-20
BR	81923050002	Equipamento para Avaliação da Acuidade Visual - Família Med Tec VA	Class I
BR	81923050003	Campimetro Digital para Teste de Visão Periférica Horizontal	Class I
BR	80344989030	CARTUCHOS	Class II
SA	ME0000002101SFDAA00071	Monarch™ Overhead Arm Positioner	—
SA	ME0000002101SFDAA00051	Bra Extender	—
CA	64113	EMS NEOPRENE HIGH RISK MEDICAL GLOVES	Class II
CA	64114	LATEX MEDICAL EXAMINATION GLOVES	Class II
CA	64115	NITRILE MEDICAL EXAMINATION GLOVES	Class II

Med-Tec,Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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