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SILIPOS Holding LLC

USA · Niagara Falls

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 4 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

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 4 510(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

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

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

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: SILIPOS Holding LLC · SILIPOS INC

FDA 510(k) clearances by year

31994 · K944240

11996 · K955664

FDA listed device types

Cover, Limb 1Protector, Skin Pressure 1Splint, Temporary Training 1Device, Prosthesis Alignment 1Insoles, Medical 1Elastomer, Silicone, For Scar Management 1Dressing, Wound, Occlusive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K955664	STERILIZED TRI BLOCK POLYMER GEL SHEET	1996-02-28
US	K944240	SOFT SOCK	1994-12-27
US	K942695	TRI BLOCK POLUMER GEL SHEETING	1994-11-10
BR	80335490003	COMPONENTES E ARTIGOS PARA PRÓTESES ORTOPÉDICAS EXTERNAS DE MEMBRO INF	Class I

SILIPOS Holding LLC

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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