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Exelint International Co.

USA · Redondo Beach CA · www.exelmed.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000037396

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Israel — 7 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 60Class IIa 234Class III 6

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

14listed device types

Class I 8Class II 6Class III 0

plus 26 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 2Class IIa 15Class III 1

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

10active device licences

Class II 10

28 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 1Class III 1IIa 14IIb 3Class 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 Union435 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States26 registration records, 7 510(k), 0 PMA, 1 excluded

United Kingdom18 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: EXELINT INTERNATIONAL, CO. · EXELINT INTERNACIONAL CO

Regulatory identity

EU manufacturer SRN: US-MF-000037396
EU authorised representative: Emergo Europe B.V.
UK responsible person: Advena Ltd

FDA 510(k) clearances by year

12000 · K001496

22001 · K010197

12003 · K020189

12010 · K101309

12015 · K152183

12025 · K251089

FDA listed device types

showing 8 of 14

Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, I.V. Fluid Transfer 1Syringe, Antistick 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Syringe, Irrigating (Non Dental) 1Container, Specimen, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	10020221260462	EXEL Disposable Syringe with Needle, 1mL 25G x 5/8" W/ Permanently Attached Needle	Class IIa
EU	00020221266115	EXEL Disposable Syringe with Needle, 3mL Luer Slip Tip W/ 20G x 1"	Class IIa
EU	00020221266085	EXEL Disposable Syringe with Needle, 3mL Luer Slip Tip W/ 21G x 1"	Class IIa
EU	00020221266054	EXEL Disposable Syringe with Needle, 3mL Luer Slip Tip W/ 22G x 1"	Class IIa
UK	58977	EXEL 105" IV ADMIN SET 15 DROP W/ 2 Y INJECTION SITES, 2 OCCLUSION CLAMPS, ROLLER CLAMP AND SLIP-LOCK CONNECTOR	Class IIa
UK	58497	EXEL Holder with Luer Lock Multi Sample Luer Adapter Sterile	Class IIa
UK	58497	EXEL Holder with Luer Lock Multi Sample Luer Adapter Sterile	Class IIa
US	K251089	EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle	2025-12-12
US	K152183	EXELINT SecureTouch Safety Hypodermic Needle	2015-11-02
US	K101309	EXELINT ALUMINUM HUB BLUNT NEEDLES	2010-10-20
BR	80117580453	Exelint Comfort Point Insulin Pen Needle	Class II
CA	10138	EXEL FISTULA NEEDLES	Class II
CA	64378	PEN NEEDLES	Class II
CA	64381	SECURETOUCH SAFETY SYRINGE	Class II

Exelint International Co.

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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