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BIODERMIS CORPORATION

USA · Henderson

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Israel, Russia — 5 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

1listed device types

Class I 1Class II 0Class III 0

plus 4 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States4 registration records, 5 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: BIODERMIS LLC · BIODERMIS CORPORATION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K003948	EPI-DERM SILICONE GEL SHEETING	2001-01-29
US	K992146	SCARAID SILICONE GEL SHEETING	1999-07-30
US	K991604	EPI-FOAM SILICONE SHEETING	1999-06-09
BR	82320590001	SCAR AID® FABRIC SILICONE GEL SHEETING	Class I
BR	81548030001	EPIFOAM	Class I
BR	81548030002	EPI-DERM	Class I

BIODERMIS CORPORATION

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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