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LUDLOW TECHNICAL PRODUCTS CANADA LTD.

Canada · Gananoque

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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

18listed device types

Class I 9Class II 8Class III 1

plus 20 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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States20 registration records, 6 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) · LUDLOW TECHNICAL PRODUCTS CANADA LTD.

Same-named companies — This database also contains companies with near-identical names: Ludlow Technical Products, Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11990 · K904185

11993 · K931903

31997 · K973110

11999 · K991235

FDA listed device types

showing 8 of 18

Stand, Infusion 1Binder, Abdominal 1Board, Arm (With Cover), Sterile 1Pad, Neonatal Eye 1Instrument, Manual, Surgical, General Use 1Board, Arm (With Cover), Non-Sterile 1Tray, Surgical, Instrument 1Clamp, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K991235	SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)	1999-07-08
US	K973110	LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD	1997-10-21
US	K972646	AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES	1997-08-21
CA	81606	FETAL SPIRAL ELECTRODE (FSE)	Class II

LUDLOW TECHNICAL PRODUCTS CANADA LTD.

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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