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Origin Medsystems, Inc.

USA · Menlo Park

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

50510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 50 510(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

28active device licences

Class II 23Class III 5

TWTaiwanTFDA

0valid device licences

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 States0 registration records, 50 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 1 excluded

Canada28 confirmed, 0 excluded

Manufacturer names merged into this page: ORIGIN MEDSYSTEMS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K992353	BLUNT TIP TROCAR PORT	1999-07-30
US	K981700	VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM	1998-05-29
US	K972685	ORIGIN LIGATOR DEVICE	1997-10-01
CA	5944	ORIGIN UNIVERSAL SEAL	Class II
CA	6816	ORIGIN SINGLE USE TROCAR SLEEVE	Class II
CA	6821	THORACIC SURGICAL TROCAR (SINGLE USE)	Class II

Origin Medsystems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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