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WELLS JOHNSON CO.

USA · Tucson

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Russia — 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

6listed device types

Class I 2Class II 4Class III 0

plus 6 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States6 registration records, 15 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: WELLS JOHNSON CO. · Wells Johnson

FDA 510(k) clearances by year

51983

11984

11985

11994

41995

11997

21999

FDA listed device types

Pump, Infusion 1Tubing, Noninvasive 1Pump, Portable, Aspiration (Manual Or Powered) 1Bottle, Collection, Vacuum 1Cannula, Surgical, General & Plastic Surgery 1Stand, Infusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K991437	WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00	1999-08-30
US	K984448	BIRCOLL BALLOON DISSECTOR	1999-01-28
US	K971580	UAS ULTRASONIC ASPIRATOR SYSTEM	1997-12-09
SA	ME0000010437SFDAA00013	MUFFLER	—
SA	ME0000010437SFDAA00011	SORENSON LINERS	—

WELLS JOHNSON CO.

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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