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Spengler SAS Spengler Group

France · Aix-en-Provence · www.gsh-med.fr

✓ Record-verifiedregistrations found in 2 marketsEU SRN FR-MF-000041197

This company has registrations in European Union, United Kingdom — 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

201UDI-DI device records

Class I 201

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 6Class IIa 3Class IIb 1

BRBrazilANVISA

0registered devices

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.

European Union201 raw hits, 0 excluded, 201 confirmed

United Kingdom10 confirmed, 0 excluded

Brazil0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN: FR-MF-000041197
UK responsible person: Compliance Solutions (Lifesciences) Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03700446028091	Brassard PNI LIAN® coton motifs raccord vis mâle nourrisson (XXS)	Class I
EU	03700446008772	Brassard PNI LIAN® CLASSIC coton motifs 2 tubes nourrisson (XXS)	Class I
EU	03700468209720	Cuissard PNI Soft Cuff® 2 poches adulte (39-55cm) DDM	Class I
EU	03700468207689	Brassard PNI Soft Cuff® 2 poches large adulte (33-41cm) DDM	Class I
UK	16156	ALLTIME	Class I
UK	16173	AUTOTENSIO	Class IIa
UK	34978	EASY CUFF	Class I

Spengler SAS Spengler Group

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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