HomeUSAPRIVATE LABEL PRODUCTIONS, LLC

PRIVATE LABEL PRODUCTIONS, LLC

USA · Bonita Springs
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
2listed device types
Class I 1Class II 1Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 10Class II 3
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
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 States5 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil13 confirmed, 0 excluded
Manufacturer names merged into this page: PRIVATE LABEL PRODUCTS, INC. · PRIVATE LABEL PRODUCTIONS, LLC · PRIVATE LABEL INDUSTRIA DE DISPOSITIVOS MEDICOS LTDA.
Same-named companies — This database also contains companies with near-identical names: PRIVATE LABEL INDUSTRIA DE DISPOSITIVOS MEDICOS LTDA., Private Label Production, LLC, PRIVATE LABEL PRODUCTS, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Bonita Springs

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

22016 · K160763

FDA listed device types

Marker, Skin 1Lubricant, Personal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK160763ally Liquid Personal Lubricant2016-06-29
USK160717ally Warming Liquid Personal Lubricant2016-06-14
BR83100040010224Scan – Laudos radiológicos com suporte de Inteligência ArtificialClass II
BR83100040001Dispositivo para a Coleta de Sangue Capilar Health ID PSDClass I
BR83100040002Dispositivo para a Coleta de Sangue Capilar Health ID PSD DUOClass I

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