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THERAGENICS CORPORATION

USA · Buford

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 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

3listed device types

Class I 1Class II 1Class III 0unclassified 1

plus 12 registration records and 5 510(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 III 4

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class III 5IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States12 registration records, 5 510(k), 0 PMA, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: THERAGENICS CORP. · THERAGENICS CORPORATION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103319	I-SEED	2011-01-03
US	K072296	POIINT OF CARE STRANDING SYSTEM, MODE 1004-00	2007-09-26
US	K043596	THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06	2005-01-26
CA	13506	THERASEED	Class III
CA	34309	ISOLOADER SYSTEM	Class III
CA	37506	ISOCARTRIDGE	Class III

THERAGENICS CORPORATION

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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