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Blue Belt Technologies, Inc.

USA · Pittsburgh

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

11listed device types

Class I 0Class II 11Class III 0

plus 18 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

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

5 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

19active ARTG entries

Class I 6IIa 11Class Is (sterile) 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States18 registration records, 22 510(k), 0 PMA, 2 excluded

Brazil5 confirmed, 1 excluded

Manufacturer names merged into this page: Blue Belt Technologies, Inc. · BLUE BELT TECHNOLOGIES, INC.

FDA 510(k) clearances by year

12012

12013

12014

22015

12016

12017

12018

12019

22020

12021

42022

12023

22024

22025

12026

FDA listed device types

showing 8 of 11

System, Image Processing, Radiological 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260601	REAL INTELLIGENCE CORI	2026-03-26
US	K252841	REAL INTELLIGENCE CORI XT (CORI XT)	2025-12-05
US	K250921	CORIOGRAPH Pre-Op Planning and Modeling Services	2025-06-25
BR	80804050383	Instrumentais RI.HIP	Class I
BR	80804059004	REAL INTELLIGENCE - CORI	Class II
BR	80804050387	R.I. Hip Modeler	Class II

Blue Belt Technologies, 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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