HomeUSAADVANCED BIO-TECHNOLOGIES, INC.

ADVANCED BIO-TECHNOLOGIES, INC.

USA · Tampa
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia, Israel, Russia — 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
1listed device types
Class I 1Class II 0Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 States2 registration records, 2 510(k), 0 PMA, 260 excluded
Brazil1 confirmed, 34 excluded
Saudi Arabia3 confirmed, 9 excluded
Canada0 confirmed, 28 excluded
Manufacturer names merged into this page: ADVANCED BIO-TECHNOLOGIES, INC. · ADVANCED BIO-TECHNOLOGIES INC · Advanced Bio-Technologies

Company information

Country
USA
City
Tampa

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

12001 · K002488
12006 · K053481

FDA listed device types

Elastomer, Silicone, For Scar Management 1

Registration details (sample)

MarketIdentifierNameClass / date
USK053481KELO-COTE SPRAY2006-04-14
USK002488KELO-COTE TOPICAL GEL2001-01-05
BR80070490001KELO-COTEClass II
SAME0000014130SFDAA00005Kelo-cote Gel
SAME0000014130SFDAA00004KELO-COTE® Spray

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