Home›Poland›Ossur Polska Sp. z o.o

Ossur Polska Sp. z o.o

Poland · Doluje Zachodniopomorskie

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

44listed device types

Class I 22Class II 22Class III 0

plus 55 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered 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 States55 registration records, 2 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: ArjoHuntleigh Polska Sp. zo.o. · LiNA Medical Polska sp. z o.o · BOWA POLSKA Sp. z o o · Philips Polska Sp. z o.o. · OTTO BOCK POLSKA SP.Z.O.O. · Nano-Tech Polska Sp. z o.o Sp. K.

Same-named companies — This database also contains companies with near-identical names: Nano-Tech Polska Sp. z o.o Sp. K., OTTO BOCK POLSKA SP.Z.O.O., Philips Polska Sp. z o.o.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12012 · K122330

12014 · K133119

FDA listed device types

showing 8 of 44

Electrosurgical, Cutting & Coagulation & Accessories 1Sleeve, Limb, Compressible 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Injection Needle, Gastroenterology-Urology 1Index-Generating Electroencephalograph Software 1Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) 1Bed, Ac-Powered Adjustable Hospital 1Laparoscope, Gynecologic (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133119	FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS	2014-02-28
US	K122330	FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE	2012-12-07
BR	10292010055	ÓRTESES E IMOBILIZADORES DE TRONCO	Class I
BR	10292010053	COMPONENTES E ARTIGOS PARA CONFECÇÃO DE ÓRTESES ORTOPÉDICAS EXTERNAS D	Class I
SA	ME0000000365SFDAA00010	Nanobiotic	—
SA	ME0000000166SFDAA00011	Nanobiotic	—

Ossur Polska Sp. z o.o

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies