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Gi Supply, Inc.

USA · Mechanicsburg

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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 1Class II 5Class III 0

plus 10 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 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

5active device licences

Class II 3Class III 2

9 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 4CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 1IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

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 States10 registration records, 10 510(k), 0 PMA, 14 excluded

Brazil1 confirmed, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: GI SUPPLY · GI Supply

FDA 510(k) clearances by year

11992

11993

11995

21997

12001

12003

22020

12023

FDA listed device types

Marker, Colon 1Pump, Portable, Aspiration (Manual Or Powered) 1General Surgery Tray 1Intrauterine Tamponade Balloon 1Submucosal Injection Agent 1Endoscopic Bite Block 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221042	Renova RP Centesis Pump	2023-04-19
US	K202376	EverLift Submucosal Lifting Agent	2020-09-30
US	K191923	EverLift Submucosal Lifting Agent	2020-06-20
BR	80375540008	Bocal Endoscópico - Biteblock	Class I
CA	65146	SPOT ENDOSCOPIC MARKER	Class II
CA	68451	VIADUCT BILIARY STENT	Class III
CA	86886	POLAR WAND ENDOSCOPIC CYROTHERAPY SYSTEM	Class III

Gi Supply, 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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