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San Diego Plastics, Inc.

USA · Mchenry

✓ 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

47listed device types

Class I 15Class II 31Class III 0unclassified 1

plus 85 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 1Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 3Class III 1

10 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 States85 registration records, 11 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Alere San Diego, Inc. · Hoya Vision Care San Diego · BD Biosciences San Diego · ALERE SAN DIEGO, INC. · ALERE SAN DIEGO, INC DBA INNOVACON, INC. · San Diego Swiss Machining Inc.

Same-named companies — This database also contains companies with near-identical names: Alere San Diego, Incorporated, BD Biosciences San Diego, Hoya Vision Care San Diego, San Diego Biotech. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21983

11994

11996

21998

12010

12012

12013

12015

12023

FDA listed device types

showing 8 of 47

Test Reagents For Ethyl Alcohol 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Thin Layer Chromatography, Tricyclic Antidepressant Drugs 1Enzyme Immunoassay, Benzodiazepine 1Gas Chromatography, Salicylate 1Thin Layer Chromatography, Methamphetamine 1Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223179	Cholestech LDX System	2023-09-20
US	K151935	Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only	2015-08-12
US	K120615	ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE	2013-05-15
BR	10071770849	SISTEMA LDX - CHOLESTECH	Class II
BR	10071770786	Perfil Lipídico/Glicose - Cholestech	Class II
BR	10071770790	Perfil Lipídico Cholestech	Class II
SA	ME0000006320SFDAA00002	IRS SUPERIOR EDITION	—
CA	68060	TRIAGE PROFILER S.O.B. PANEL	Class III
CA	84144	TRIAGE NGAL TEST	Class II
CA	85175	ALERE TRIAGE CARDIORENAL CONTROLS	Class II

San Diego Plastics, Inc.

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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