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RENU MEDICAL, INC.

USA · Everett

✓ 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

8listed device types

Class I 5Class II 3Class III 0

plus 15 registration records and 9 510(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

6active ARTG entries

Class I 6

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 States15 registration records, 9 510(k), 0 PMA

Canada1 confirmed, 0 excluded

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

FDA 510(k) clearances by year

12003

12006

22007

12009

12010

12011

12012

12021

FDA listed device types

Sleeve, Limb, Compressible 1Oximeter, Reprocessed 1Cable, Electrode 1Tourniquet, Pneumatic 1Monitor, Bed Patient 1Lift, Patient, Non-Ac-Powered 1Device, Transfer, Patient, Manual 1Infusor, Pressure, For I.V. Bags 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203847	Reprocessed Tri Pulse Compression Garment	2021-05-07
US	K121145	RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME	2012-06-12
US	K111773	RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE	2011-11-16
CA	104309	REPROCESSED COMPRESSION SLEEVES	Class II

RENU 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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