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Home›USA›Salter Labs, Division of Regulatory Affairs

Salter Labs, Division of Regulatory Affairs

USA · Arvin
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
7listed device types
Class I 6Class II 0Class III 0unclassified 1
plus 9 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
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, 6 510(k), 0 PMA
Manufacturer names merged into this page: PROCTER & GAMBLE CO., REGULATORY AFFAIRS · ALBERTA INNOVATES TECHNOLOGY FUTURES - REGULATORY AFFAIRS & COMPLIANCE
Same-named companies — This database also contains companies with near-identical names: PROCTER & GAMBLE CO., REGULATORY AFFAIRS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Arvin

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

11997 · K973148
11998 · K973590
31999 · K972383
12008 · K080922

FDA listed device types

Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt 1Dental Hygiene Kit 1Floss, Dental 1Pick, Massaging 1Cleanser, Denture, Over The Counter 1Heat Source For Bleaching Teeth 1Saliva, Artificial 1

Registration details (sample)

MarketIdentifierNameClass / date
USK080922SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR2008-07-25
USK972383EASY-JET DEVICE1999-11-23
USK973592WALKCARE P200 SYSTEM1999-05-20

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