HomeUSAAtlantic Products, Inc.

Atlantic Products, Inc.

USA · Hicksville
✓ 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
3listed device types
Class I 3Class II 0Class III 0
plus 9 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 4
5 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 States9 registration records, 1 510(k), 0 PMA, 16 excluded
Brazil2 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: Atlantic Safety Products, Inc. · Atlantic Medical Products, LLC · ATLANTIC SAFETY PRODUCTS, INC. · ATLANTIC MEDICAL PRODUCTS, LLC DBA SCAR HEAL AND REJUVASKIN

Company information

Country
USA
City
Hicksville

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

12002 · K023108

FDA listed device types

Polymer Patient Examination Glove 1Elastomer, Silicone, For Scar Management 1Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK023108STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE2002-12-03
BR82753100001Fitas de Silicone Scar Fx®Class I
BR82753100002Gel de Silicone para Cicatrizes - RejuvasilClass I
SAME0000000651SFDAA00024RejuvaSil® Silicone Scar Gel
SAME0000017694SFDAA00001Scar Fx® Silicone Sheeting
CA86395POWDER FREE NITRILE EXAMINATION GLOVESClass II
CA97819INTOUCH POWDER FREE LATEX EXAMINATION GLOVESClass II
CA97847INTOUCH POWDER FREE 100% NITRILE EXAMINATION GLOVESClass II

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