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PENUMBRA, INC.

USA · Alameda

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

12listed device types

Class I 0Class II 12Class III 0

plus 338 registration records and 87 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

32 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

20 including historic records

TWTaiwanTFDA

9valid device licences

Class II 9

SGSingaporeHSA SMDR

11device registrations

CLASS B 1CLASS D 10

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

37active ARTG entries

Class I 5Class III 28IIa 2Class Is (sterile) 2

HKHong KongMDACS

8valid listings

Class II 2Class IV 6

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

12active registrations

Class 2a 2Class 3 10

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 States338 registration records, 87 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 3 excluded

Manufacturer names merged into this page: PENUMBRA, INC. · Penumbra Inc. · PENUMBRA INC.

Business registration

Legal name: Penumbra Inc
CIK: 0001321732
Registration status: Active
Listing status: Listed (PEN)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006

22007

22008

12009

32010

32011

42012

32014

72015

92016

42017

72018

62019

82020

52021

62022

22023

72024

32025

32026

FDA listed device types

showing 8 of 12

Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Endoscope, Neurological 1Catheter, Thrombus Retriever 1Peripheral Mechanical Thrombectomy With Aspiration 1Catheter, Percutaneous, Neurovasculature 1Coronary Mechanical Thrombectomy With Aspiration 1Catheter, Angioplasty, Peripheral, Transluminal 1Device, Neurovascular Embolization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250690	Penumbra System (Thunderbolt Aspiration Tubing)	2026-06-10
US	K260599	INDIGO® Aspiration System INDIGO Link	2026-04-24
US	K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	2026-02-05
BR	81248529002	Sistema de Acesso Vascular ELEMENT	Class II
BR	81248520001	MANOPLA DE LIBERAÇÃO	Class I
BR	81248529003	Separador INDIGO	Class II