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PolyGel, LLC

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, United Kingdom, Saudi Arabia, 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

0UDI-DI device records

USUnited StatesFDA openFDA

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

7registered 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

3active ARTG entries

Class I 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 States9 registration records, 0 510(k), 0 PMA

United Kingdom9 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Manufacturer names merged into this page: POLYGEL LLC. · polygel, LLC

Regulatory identity

UK responsible person: Qserve Group UK, Ltd.

FDA listed device types

showing 8 of 9

Orthosis, Corrective Shoe 1Exerciser, Non-Measuring 1Orthosis, Limb Brace 1Protector, Skin Pressure 1Phantom, Anthropomorphic, Radiographic 1Insoles, Medical 1Pack, Hot Or Cold, Reusable 1Elastomer, Silicone, For Scar Management 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	13565	ALL GEL 5TH TOE BUNION GUARD	Class I
UK	61023	DRY EYE MOISTURE H/C MASK - SILICA BEAD	Class I
UK	63065	DRY EYE MOISTURE H/C MASK - SILICA BEAD	Class I
SA	ME0000014201SFDAA00009	gelsmart	—
SA	ME0000014201SFDAA00001	Natracure	—

PolyGel, LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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