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BIOMERICS LLC

USA · Salt Lake City

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

17listed device types

Class I 3Class II 14Class III 0

plus 20 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class II 20

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

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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 States20 registration records, 2 510(k), 0 PMA, 9 excluded

Brazil20 confirmed, 0 excluded

Manufacturer names merged into this page: BIOMERICS · BIOMERICS LLC

FDA 510(k) clearances by year

12012 · K121773

12020 · K190259

FDA listed device types

showing 8 of 17

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Probe, Radiofrequency Lesion 1Apparatus, Cautery, Radiofrequency, Ac-Powered 1System, Perfusion, Kidney 1Cannula, Catheter 1Catheter Introducer Kit 1Introducer, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190259	Vesta RF Cannula	2020-02-07
US	K121773	NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE	2012-09-21
BR	81420890005	Kit Cânula Nimbus Pro Microwave Expansível.	Class II
BR	81420890001	NIMBUS LITE - KIT CÂNULA PARA RADIOFREQUÊNCIA	Class II
BR	81420890014	NIMBUS SIJ-KIT - KIT CÂNULA CIRÚRGICO DESCARTÁVEL PARA DENERVAÇÃO SACR	Class II

BIOMERICS LLC

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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