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OriGen Biomedical, Inc.

USA · Austin

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 1Class III 0unclassified 1

plus 14 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

8 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 1IIb 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States14 registration records, 4 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: OriGen Biomedical, Inc. · ORIGEN BIOMEDICAL INC

FDA 510(k) clearances by year

22001 · K003288

12002 · K021702

12012 · K113869

FDA listed device types

Container, Empty, For Collection & Processing Of Blood & Blood Components 1Flask, Tissue Culture 1Container, Specimen, Sterile 1Tube, Tissue Culture 1Device, Heat-Sealing 1Container, Frozen Donor Tissue Storage 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K113869	ORIGEN REINFORCED DUAL LUMEN CATHETER	2012-07-26
US	K021702	CRYOBAG, MODEL CB	2002-08-06
US	K003288	ORIGEN DUAL LUMEN CATHETER	2001-06-08
BR	80089939001	ADAPTADORES PLÁSTICOS	Class II
CA	70810	DUAL LUMEN CANNULA	Class II
CA	79472	PERFLUOROCARBON BRONCHIAL LAVAGE SOLUTIONS	Class II
CA	90885	PERCUTANEOUS INTRODUCER KIT	Class II

OriGen Biomedical, 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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