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UreSil , LLC

✓ Record-verifiedregistrations found in 9 marketsEU SRN US-MF-000008244

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 9 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

14UDI-DI device records

Class I 5Class IIa 1Class III 8

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 3Class III 0unclassified 1

plus 8 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

22registered device records

Class I 9Class IIa 11System or Procedure Pack 2

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

6active device licences

Class II 6

10 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

IIa 5Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 Union14 raw hits, 0 excluded, 14 confirmed

United States8 registration records, 48 510(k), 0 PMA, 1 excluded

United Kingdom22 confirmed, 0 excluded

Brazil4 confirmed, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: URESIL, LLC · URESIL · URESIL LLC

Regulatory identity

EU manufacturer SRN: US-MF-000008244
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

11981

91986

61987

11988

31990

21991

61992

41993

31994

31995

21997

41998

12001

12004

12005

12010

FDA listed device types

Stents, Drains And Dilators For The Biliary Ducts 1Bottle, Collection, Vacuum 1Bag, Bile Collecting 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Tape And Bandage, Adhesive 1Accessories, Catheter 1Catheter, Nephrostomy, General & Plastic Surgery 1Catheter, Nephrostomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00817640021759	Tru-Close	Class I
EU	00817640021728	Tru-Close	Class I
EU	00817640021766	Tru-Close	Class I
EU	00817640021735	Tru-Close	Class I
UK	10696	Chole-Cath Biliary Drainage Catheter	Class IIa
UK	10696	Chole-Cath Biliary Drainage Catheter Procedure Pack	System or Procedure Pack
UK	11301	Percutaneous Drainage Catheter Connector Tubing	Class I
US	K093653	URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK	2010-02-23
US	K053245	GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER	2005-12-20
US	K041995	MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY	2004-08-19
BR	10350530086	INTRODUTOR POSI-STICK	Class II
BR	10350530120	CONJUNTO PARA DRENAGEM URESIL	Class II
BR	10350530025	CATETER PARA VENTILAÇÃO TORÁCICA TRU-CLOSE	Class II
CA	99822	SYMPHONY CENTESIS DRAINAGE KIT	Class II
CA	100369	CATHETER FIXATION KIT	Class II
CA	103460	ULTI-FLO NON-LOCKING HYDROPHILIC-COATED CATHETER	Class II

UreSil , LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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