Home›France›COLOPLAST MANUFACTURING FRANCE, SAS

COLOPLAST MANUFACTURING FRANCE, SAS

France · Le Plessis-Robinson

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 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

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 2Class II 9Class III 0unclassified 1

plus 22 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

37active device licences

Class II 35Class III 2

TWTaiwanTFDA

1valid device licences

Class I 1

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.

United States22 registration records, 0 510(k), 0 PMA, 15 excluded

Brazil1 confirmed, 6 excluded

Canada37 confirmed, 4 excluded

Manufacturer names merged into this page: COLOPLAST MANUFACTURING FRANCE, SAS · COLOPLAST MANUFACTURING FRANCE SAS · COLOPLAST MANUFACTURING FRANCE

FDA listed device types

showing 8 of 12

Dislodger, Stone, Basket, Ureteral, Metal 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Catheter, Ureteral, Gastro-Urology 1Dilator, Catheter, Ureteral 1Stent, Ureteral 1Catheter, Retention Type, Balloon 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10430310058	DORMIA PICKSTONE	Class II
CA	24901	SINGLE LOOP URETERAL STENT	Class II
CA	24902	URETERIC CATHETERS - DISPOSABLE - RADIOPAQUE	Class II
CA	25239	DOUBLE LOOP URETERAL STENT	Class III

COLOPLAST MANUFACTURING FRANCE, SAS

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies