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BALT EXTRUSION SAS

France · Montmorency

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

5listed device types

Class I 0Class II 5Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

26 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

10active device licences

Class II 10

27 including historic records

TWTaiwanTFDA

7valid device licences

Class II 6Class III 1

SGSingaporeHSA SMDR

5device registrations

CLASS D 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

17active ARTG entries

Class III 15IIa 2

HKHong KongMDACS

23valid listings

Class II 1Class IV 22

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

18active registrations

Class 2a 1Class 3 17

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 States3 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 3 excluded

Canada10 confirmed, 1 excluded

Manufacturer names merged into this page: BALT EXTRUSION · BALT EXTRUSION SAS

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81936219003	introdutores iva balt longo	Class II
BR	81936219004	INTRODUTORES IVA BALT CURTO	Class II
BR	81936219002	conectores balt	Class II
CA	62303	SORCERER-NITINOL HYDROPHILIC MICROGUIDE	Class II
CA	64268	CONNECTOR	Class II
CA	64269	LARIBOISIERE CATHETER	Class II

BALT EXTRUSION SAS

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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