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BIOPRO, INC.

USA · Port Huron

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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

45listed device types

Class I 14Class II 31Class III 0

plus 80 registration records and 41 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class II 1

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

2active device licences

Class III 2

6 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 2IIb 3

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 States80 registration records, 41 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BIOPRO, INC. · BIOPRO INC.

FDA 510(k) clearances by year

21988

31989

51991

11992

11993

21994

11996

11999

12000

32001

22004

22005

22006

12007

22008

22009

22010

12012

22013

22017

FDA listed device types

showing 8 of 45

Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Apparatus, Air Handling, Room 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Bone Wedge 1Screw, Fixation, Bone 1Prosthesis, Hip, Femoral, Resurfacing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163627	Shotel Ankle Arthrodesis Nail System	2017-09-14
US	K162674	BioPro Foot Plating Systems	2017-06-16
US	K132510	BIOPRO - INFINITY PLATE ANCHOR SYSTEM	2013-10-24
BR	80530189003	INSTRUMENTAL PARA PARAFUSO DE COMPRESSÃO HBS BIOPRO	Class I
BR	80530180061	Effi+Pro® Kit Compressão/Distração	Class I
BR	80530180062	Break-Out® Extrator de Parafuso Canulado	Class I
CA	101883	BIOPRO HEADLESS BONE SCREW (HBS)	Class III
CA	101904	BIOPRO GO-EZ SCREW	Class III

BIOPRO, INC.

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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