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ZEVEX, INC.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, South Korea, Australia, Israel — 5 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

9listed device types

Class I 1Class II 6Class III 0unclassified 2

plus 11 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

13active device licences

Class II 11Class III 2

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 1IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States11 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: ZEVEX, INC.

FDA 510(k) clearances by year

12001 · K012147

12014 · K131154

12015 · K142539

22024 · K242660

FDA listed device types

showing 8 of 9

Instrument, Vitreous Aspiration And Cutting, Ac-Powered 1Pump, Infusion 1Set, Administration, Intravascular 1Pump, Infusion, Enteral 1Unit, Phacofragmentation 1Gastrointestinal Tubes With Enteral Specific Connectors 1Instrument, Ultrasonic Surgical 1Neurosurgical Ultrasonic Instruments 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242660	Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets	2024-10-03
US	K232793	Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets	2024-05-17
US	K142539	EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set	2015-01-08
CA	14821	ENTERALITE AMBULATORY ENTERAL FEEDING PUMP	Class II
CA	14822	ENTERALITE ENTERAL DELIVERY SET	Class II
CA	64601	CLINICAL MANAGEMENT SYSTEM (CMS)	Class III

ZEVEX, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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