HomeUSAVITALITEC INTERNATIONAL INC.

VITALITEC INTERNATIONAL INC.

USA · Domalain
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong — 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
18listed device types
Class I 14Class II 4Class III 0
plus 22 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
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
1 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 4IIa 3
HKHong KongMDACS
1valid listings
Class II 1
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 States22 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Vitalitec International Medizintechnik GmbH · VITALITEC INTERNATIONAL · VITALITEC INTERNATIONAL INC. · VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH
Same-named companies — This database also contains companies with near-identical names: Vitalitec International Medizintechnik GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Domalain

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 listed device types

showing 8 of 18
Rongeur 1Forceps 1Instrument, Ligature Passing And Knot Tying 1Holder, Needle, Gastroenterologic 1Bur, Surgical, General & Plastic Surgery 1Accessories, Arthroscopic 1Scissors, General, Surgical 1Saw, Manual And Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10230390044Pinça para oclusão cirúrgica temporáriaClass I
BR10230390045Clips/Clamps de Oclusão TemporáriaClass II
BR10230390043Insertos INTRACKClass II

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