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Microtek Medical B.V.

Netherlands · Zutphen Gelderland

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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

30listed device types

Class I 10Class II 19Class III 0unclassified 1

plus 57 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 9Class II 7

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

12active device licences

Class II 12

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class Is (sterile) 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 4

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 States57 registration records, 26 510(k), 0 PMA, 5 excluded

Brazil16 confirmed, 1 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: Microtek Medical LLC · Microtek Medical B.V. · MICROTEK MEDICAL MALTA LIMITED · Microtek Medical B.V. Varsseveld · PLASCO, A DIVISION OF MICROTEK MEDICAL, INC. · MICROTEK MEDICAL LLC

FDA 510(k) clearances by year

81984

11985

31986

11987

11994

11995

22001

22002

12005

12006

12007

22011

12014

12025

FDA listed device types

showing 8 of 30

Accessory, Surgical Apparel 1Urinal 1Accessories, Arthroscopic 1Bag, Intestine 1Warmer, Irrigation Solution 1Airway, Oropharyngeal, Anesthesiology 1Bedding, Disposable, Medical 1Shield, Protective, Personnel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251676	Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)	2025-09-16
US	K133554	SURGICAL LIGHT HANDLE COVER	2014-04-08
US	K110358	VENODYNE V810	2011-05-05
BR	80053550036	CAPA PROTETORA PARA EQUIPAMENTOS MICROTEK	Class I
BR	80053550038	CAPA PROTETORA PARA MICROSCÓPIOS MICROTEK	Class I
BR	10302860154	Capas Estéreis Microtek	Class I
SA	ME0000011597SFDAA00001	Microtek ™ / Ecolab	—
SA	ME0000011641SFDAA00035	Microtek™ / ECOLAB	—
CA	1713	ENTERAL FEEDING SYSTEMS	Class II
CA	66838	COMPRESSION SLEEVES	Class II
CA	1415	CPR MICROMASK	Class II

Microtek Medical B.V.

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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