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Puritan Medical Products Company, LLC

USA · Pittsfield

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Israel — 6 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

14listed device types

Class I 12Class II 2Class III 0

plus 18 registration records and 8 510(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

2 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States18 registration records, 8 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 5 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: PURITAN MEDICAL PRODUCTS, LLC · PURITAN MEDICAL PRODUCTS COMPANY LLC · Puritan Medical Products Company, LLC · HARDWOOD PRODUCTS COMPANY LP ADBA PURITAN MEDICAL PRODUCTS COMPANY LLC

FDA 510(k) clearances by year

32012 · K120846

12013 · K131630

12015 · K142366

22016 · K162284

12025 · K242820

FDA listed device types

showing 8 of 14

System, Transport, Aerobic 1Device, Specimen Collection 1Culture Media, Non-Propagating Transport 1Splint, Hand, And Components 1Transport Systems, Anaerobic 1Applicator, Absorbent Tipped, Non-Sterile 1Culture Media, Selective And Non-Differential 1Tape, Measuring, Rulers And Calipers 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242820	Puritan PurSafe Plus Collection and Transport System	2025-05-27
US	K162284	Puritan Fecal Opti-Swab Collection and Transport System	2016-11-04
US	K160082	Puritan Opti-Tranz Cary-Blair Collection and Transport System	2016-07-29

Puritan Medical Products Company, LLC

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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