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BRM EXTREMITIES SRL

Italy · Civate (Lc) Lombardy

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

6listed device types

Class I 3Class II 3Class III 0

plus 7 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 7Class II 2

18 including historic records

SASaudi ArabiaSFDA

0registered 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 States7 registration records, 4 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: BRM EXTREMITIES SRL · BRM EXTREMITIES S.R.L - SEDE LEGAL (VIA LORENZO MASCHERONI) · BRM EXTREMITIES S.R.L.

FDA 510(k) clearances by year

12020 · K191966

22022 · K222820

12023 · K220142

FDA listed device types

Prosthesis, Toe, Constrained, Polymer 1Screw, Fixation, Bone 1Prosthesis, Finger, Constrained, Polymer 1Bit, Drill 1Orthopedic Manual Surgical Instrument 1Burr, Orthopedic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220142	BRM Digitalis Spacer	2023-04-04
US	K222820	BRM TOOL Screws, BIOPLAN Subtalar Implant	2022-12-16
US	K203773	BRM TOOL Screws	2022-01-14
BR	10242780135	KIT DE INSTRUMENTAL BIOPLAN	Class I
BR	10242780136	KIT DE INSTRUMENTAL LINHA TOOL	Class I
BR	10242780132	KIT DE INSTRUMENTAL SILKTOE	Class I

BRM EXTREMITIES SRL

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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