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Applied Clinical Research Laboratories

USA · Mchenry

✓ 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 3Class II 2Class III 0unclassified 2

plus 11 registration records and 42 510(k), 10 PMA

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

2 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 States11 registration records, 42 510(k), 10 PMA, 75 excluded

Brazil0 confirmed, 10 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: APPLIED LABORATORIES, INC. · APR APPLIED PHARMA RESEARCH S.A. · APPLIED DIABETES RESEARCH, INC.

FDA 510(k) clearances by year

71977

111978

61979

11980

11981

21984

11985

11986

11987

61988

12001

22003

12004

12015

FDA listed device types

Lice Removal Kit Containing A Solution 1Nasal Spray, Ent Delivery 1Applicator, Ent 1High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist 1Lubricant, Personal 1Saliva, Artificial 1Dressing, Wound, Drug 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151168	Nexodyn AOS Wound Care Solution	2015-12-22
US	K041152	THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A	2004-05-24
US	K033099	ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109	2003-10-16

Applied Clinical Research Laboratories

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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