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GARWARE FULFLEX USA, INC.

USA · Brattleboro

✓ 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

18listed device types

Class I 15Class II 3Class III 0

plus 22 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

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 States22 registration records, 0 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Garware Fulflex Texas Inc. · Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.) · Garware Fulflex India Private Ltd (Formerly Garware Bestretch Ltd) · GARWARE FULFLEX USA, INC. · GARWARE FULFLEX USA INC

FDA listed device types

showing 8 of 18

Exerciser, Non-Measuring 1Container, Specimen Mailer And Storage, Sterile 1Stand, Infusion 1Bag, Ice 1Container, Liquid Medication, Graduated 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1Dressing, Compression 1Tubing, Pressure And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81901670007	HAND GRIP ANEL DE BORRACHA LATEX FREE MEDSAFE FULFLEX	Class I
BR	81901670008	BARRA DE RESISTÊNCIA E TORÇÃO LATEX FREE MEDSAFE FULFLEX	Class I
BR	81901670009	BOLA DE MASSAGEM LACROSSE SPIKE LATEX FREE MEDSAFE FULFLEX	Class I

GARWARE FULFLEX USA, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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