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HANS RUDOLPH, INC.

USA · Shawnee

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel, Russia — 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

6listed device types

Class I 4Class II 2Class III 0

plus 6 registration records and 11 510(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

3active device licences

Class II 3

16 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 3IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States6 registration records, 11 510(k), 0 PMA, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: HANS RUDOLPH, INC. · HANS RUDOLPH INC.

FDA 510(k) clearances by year

11979

11993

11994

21995

21996

12002

22003

12008

FDA listed device types

Tape And Bandage, Adhesive 1Mask, Oxygen, Non-Rebreathing 1Calibrator, Volume, Gas 1Mask, Oxygen 1Ventilator, Non-Continuous (Respirator) 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071149	HRI 6500, 6600 AND 6700 SERIES V2MASKS	2008-02-01
US	K030822	7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS	2003-06-03
US	K030515	HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS	2003-05-02
CA	6173	FACE MASK FOR ANESTHESIA	Class II
CA	9150	BREATHING TUBING	Class II
CA	9164	ULTIMATE SEAL	Class II

HANS RUDOLPH, 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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