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HAGER WORLDWIDE, INC.

USA · Hickory

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

37listed device types

Class I 36Class II 1Class III 0

plus 37 registration records and 3 510(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

TWTaiwanTFDA

pendingnot queried

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 States37 registration records, 3 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: HAGER WORLDWIDE, INC.

FDA 510(k) clearances by year

22005 · K043322

12006 · K061933

FDA listed device types

showing 8 of 37

Light, Fiber Optic, Dental 1Forceps 1Frame, Rubber Dam 1Evacuator, Oral Cavity 1Anaerobic Box Glove 1Toothbrush, Manual 1Material, Impression Tray, Resin 1Instrument, Contouring, Matrix, Operative 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061933	HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER	2006-11-16
US	K043322	MIRAMATIC SAFE SYRINGE SYSTEM	2005-07-21
US	K050658	RESO-PAC PERIODONTAL DRESSING	2005-05-27

HAGER WORLDWIDE, 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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