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GERGONNE INDUSTRIE S.A.S.

France · Oyonnax Cedex · www.gergonne.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN FR-MF-000003647

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel — 6 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

16UDI-DI device records

Class I 16

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class I 1

BRBrazilANVISA

4registered devices

Class I 2Class II 2

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

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

European Union16 raw hits, 0 excluded, 16 confirmed

United States1 registration records, 0 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: GERGONNE INDUSTRIE

Regulatory identity

EU manufacturer SRN: FR-MF-000003647
UK responsible person: Qserve Group UK, Ltd.

Business registration

Legal name: GERGONNE INDUSTRIE
LEI: 9695007EAYEKTU8HSY46
Registration status: Active
Legal form: société par actions simplifiée (SAS)
Incorporated: 2006-02-27
Registered address: RUE DE TAMAS, OYONNAX, 01100
Registration authority: Register of Companies (Sirene), no. 488899972
Registry record updated: 2026-04-11

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03701487600055	IRIS	Class I
EU	03701487600024	MINIMOZ	Class I
EU	03701487600031	PAPYRUS	Class I
EU	03701487600123	PAPYRUS	Class I
UK	34864	BAXTER PLASTER	Class I
BR	80567510018	OSMOZ	Class I
BR	80567519006	PAPYRUS	Class II
BR	80567519007	MOZAIK	Class II

GERGONNE INDUSTRIE S.A.S.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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