HomeUSAMEDICAL PRODUCTS LABORATORIES, INC.

MEDICAL PRODUCTS LABORATORIES, INC.

USA · Philadelphia
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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
6listed device types
Class I 2Class II 3Class III 0unclassified 1
plus 8 registration records and 2 510(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
2GMP quality-system certificates
Import 2
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 States8 registration records, 2 510(k), 0 PMA, 136 excluded
Brazil0 confirmed, 56 excluded
Saudi Arabia0 confirmed, 10 excluded
Canada0 confirmed, 70 excluded
Manufacturer names merged into this page: MEDICAL PRODUCTS LABORATORIES, INC.

Company information

Country
USA
City
Philadelphia

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

11985 · K844572
12004 · K040098

FDA listed device types

Agent, Polishing, Abrasive, Oral Cavity 1Preparer, Root Canal Endodontic 1Lubricant, Personal 1Drink, Glucose Tolerance 1Varnish, Cavity 1Cord, Retraction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK040098VARNISHAMERICA2004-02-04
USK844572PRE-KLENE ENAMEL CLEANER1985-01-18

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