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Robling Medical, Inc.

USA · Youngsville

✓ Record-verifiedregistrations found in 3 markets

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

35listed device types

Class I 3Class II 29Class III 1unclassified 2

plus 53 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

4active device licences

Class II 4

5 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

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 States53 registration records, 2 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ROBLING MEDICAL, LLC · ROBLING MEDICAL, INC.

FDA 510(k) clearances by year

22016 · K160795

FDA listed device types

showing 8 of 35

Electrosurgical, Cutting & Coagulation & Accessories 1Coronary Artery Disease Machine Learning-Based Notification Software 1Cystoscope And Accessories, Flexible/Rigid 1Temporary, Internal Use Hemostatic 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Urinometer, Electrical 1System, Suction, Lipoplasty For Removal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160795	United Urologics Intermittent Catheter	2016-06-16
US	K160877	United Urologics Closed System Catheter	2016-05-20
CA	64112	INTERMITTENT URINARY CATHETER - PVC	Class II
CA	80273	HEMOBAG BLOOD SALVAGE DEVICE	Class II
CA	80274	TS3 TUBING SET	Class II

Robling Medical, 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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