HomeUSAMedi-Tech, Inc.

Medi-Tech, Inc.

USA · Mchenry
✓ 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
13listed device types
Class I 5Class II 8Class III 0
plus 17 registration records and 47 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 2Class II 11
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
2 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 States17 registration records, 47 510(k), 0 PMA, 80 excluded
Brazil13 confirmed, 19 excluded
Saudi Arabia0 confirmed, 11 excluded
Canada0 confirmed, 12 excluded
Manufacturer names merged into this page: REMAX MEDI-TECH(SHENZHEN) CORPORATION · BLAZEJEWSKI MEDI-TECH GMBH · ORTUS MEDI-TECH CO., LTD. · MIRAE MEDI&TECH CO., LTD. · MIRAE MEDI&TECH CO., LTD · REMAX MEDI-TECH (SHENZHEN) CORPORATION
Same-named companies — This database also contains companies with near-identical names: S. M. C. Medi-Tech Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mchenry

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11978
11979
31981
21982
11983
51984
31985
21986
41987
31988
51989
11990
51994
21995
11996
42001
22002
12009
12011

FDA listed device types

showing 8 of 13
Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Hysteroscope (And Accessories) 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Syringe, Balloon Inflation, Exempt 1Stimulator, Electrical, Transcutaneous, For Arthritis 1Laser, Comb, Hair 1

Registration details (sample)

MarketIdentifierNameClass / date
USK110377PROTECTIVE RESTRAINT2011-04-25
USK082841SPINAL FORAMINOSCOPE2009-09-09
USK023870FLEXIMA BILIARY CATHETER2002-12-20
BR81506640023BANDAGEM DE COMPRESSÃO FEMORAL DESCARTÁVEL ORTUSClass I
BR10210419011CONECTOR EM YClass II
BR10210419012MANIFOLDClass II

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