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Wiltek Medical, Inc.

USA · Winston-Salem

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

21510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 21 510(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

4active device licences

Class II 4

TWTaiwanTFDA

pendingnot queried

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 States0 registration records, 21 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: WILTEK MEDICAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K990231	WILTEK HOT BIOPSY FORCEPS	1999-04-13
US	K922989	WILTEK IRRIGAITON/ASPIRATION TUBE SET	1994-02-15
US	K930419	WILTEK BIOPSY FORCEPS	1993-06-01
CA	1821	BALLOON CHOLANGIOGRAPHY CATHETERS	Class II
CA	1823	BIOPSY FORCEPS	Class II
CA	1826	LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS	Class II

Wiltek Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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